Trial Outcomes & Findings for S0802 - Topotecan With or Without Aflibercept in Treating Patients With Extensive-Stage Small Cell Lung Cancer (NCT NCT00828139)
NCT ID: NCT00828139
Last Updated: 2017-08-21
Results Overview
From the date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Progression is defined as 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
189 participants
Primary outcome timeframe
Disease assessments were performed every 6 weeks, up to 2 years.
Results posted on
2017-08-21
Participant Flow
Participant milestones
| Measure |
Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept
Patients with platinum sensitive (complete response or partial response and \> 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
|
Platinum Sensitivity Treated With Topotecan Alone
Patients with platinum sensitivity treated with topotecan alone
|
Platinum Refractory Treated With Topotecan + Ziv-aflibercept
Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and \< 180 days for limited stage) treated topotecan and ziv-aflibercept.
|
Platinum Refractory Treated With Topotecan Aloine
Patients with platinum refractory treated topotecan alone.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
42
|
41
|
55
|
51
|
|
Overall Study
COMPLETED
|
1
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
41
|
41
|
55
|
51
|
Reasons for withdrawal
| Measure |
Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept
Patients with platinum sensitive (complete response or partial response and \> 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
|
Platinum Sensitivity Treated With Topotecan Alone
Patients with platinum sensitivity treated with topotecan alone
|
Platinum Refractory Treated With Topotecan + Ziv-aflibercept
Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and \< 180 days for limited stage) treated topotecan and ziv-aflibercept.
|
Platinum Refractory Treated With Topotecan Aloine
Patients with platinum refractory treated topotecan alone.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
8
|
1
|
10
|
5
|
|
Overall Study
Death
|
2
|
1
|
0
|
2
|
|
Overall Study
Refusal unrelated to toxicity
|
3
|
4
|
5
|
3
|
|
Overall Study
Disease Progression
|
24
|
33
|
35
|
39
|
|
Overall Study
Other
|
4
|
2
|
5
|
2
|
Baseline Characteristics
S0802 - Topotecan With or Without Aflibercept in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept
n=42 Participants
Patients with platinum sensitive (complete response or partial response and \> 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
|
Platinum Sensitivity Treated With Topotecan Alone
n=41 Participants
Patients with platinum sensitivity treated with topotecan alone
|
Platinum Refractory Treated With Topotecan + Ziv-aflibercept
n=55 Participants
Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and \< 180 days for limited stage) treated topotecan and ziv-aflibercept.
|
Platinum Refractory Treated With Topotecan Aloine
n=51 Participants
Patients with platinum refractory treated topotecan alone.
|
Total
n=189 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63.4 years
n=5 Participants
|
60.1 years
n=7 Participants
|
60.9 years
n=5 Participants
|
63.6 years
n=4 Participants
|
62.5 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
99 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
90 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
36 participants
n=5 Participants
|
40 participants
n=7 Participants
|
49 participants
n=5 Participants
|
43 participants
n=4 Participants
|
168 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
4 participants
n=4 Participants
|
12 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native American
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unknown/Other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Metastatic Disease Sites
Single lesion, single organ
|
4 participants
n=5 Participants
|
9 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
21 participants
n=21 Participants
|
|
Metastatic Disease Sites
Multiple lesions, single organ
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
11 participants
n=4 Participants
|
40 participants
n=21 Participants
|
|
Metastatic Disease Sites
Multiple lesions, multiple organs
|
25 participants
n=5 Participants
|
22 participants
n=7 Participants
|
41 participants
n=5 Participants
|
34 participants
n=4 Participants
|
122 participants
n=21 Participants
|
|
Metastatic Disease Sites
None
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
6 participants
n=21 Participants
|
|
Stage
Extensive
|
27 participants
n=5 Participants
|
23 participants
n=7 Participants
|
39 participants
n=5 Participants
|
42 participants
n=4 Participants
|
131 participants
n=21 Participants
|
|
Stage
Limited
|
15 participants
n=5 Participants
|
18 participants
n=7 Participants
|
16 participants
n=5 Participants
|
9 participants
n=4 Participants
|
58 participants
n=21 Participants
|
|
Performance Status
0
|
14 participants
n=5 Participants
|
17 participants
n=7 Participants
|
12 participants
n=5 Participants
|
19 participants
n=4 Participants
|
62 participants
n=21 Participants
|
|
Performance Status
1
|
28 participants
n=5 Participants
|
24 participants
n=7 Participants
|
43 participants
n=5 Participants
|
32 participants
n=4 Participants
|
127 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Disease assessments were performed every 6 weeks, up to 2 years.From the date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Progression is defined as 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration.
Outcome measures
| Measure |
Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept
n=42 Participants
Patients with platinum sensitive (complete response or partial response and \> 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
|
Platinum Sensitivity Treated With Topotecan Alone
n=41 Participants
Patients with platinum sensitivity treated with topotecan alone
|
Platinum Refractory Treated With Topotecan + Ziv-aflibercept
n=55 Participants
Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and \< 180 days for limited stage) treated topotecan and ziv-aflibercept.
|
Platinum Refractory Treated With Topotecan Aloine
n=51 Participants
Patients with platinum refractory treated topotecan alone.
|
|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
1.8 Months
Interval 1.5 to 2.2
|
1.3 Months
Interval 1.2 to 1.4
|
1.4 Months
Interval 1.3 to 1.7
|
1.4 Months
Interval 1.3 to 1.4
|
SECONDARY outcome
Timeframe: Weekly, up to 2 years.Estimated to within at least 15% (95% confidence interval).
Outcome measures
| Measure |
Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept
n=42 Participants
Patients with platinum sensitive (complete response or partial response and \> 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
|
Platinum Sensitivity Treated With Topotecan Alone
n=41 Participants
Patients with platinum sensitivity treated with topotecan alone
|
Platinum Refractory Treated With Topotecan + Ziv-aflibercept
n=55 Participants
Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and \< 180 days for limited stage) treated topotecan and ziv-aflibercept.
|
Platinum Refractory Treated With Topotecan Aloine
n=51 Participants
Patients with platinum refractory treated topotecan alone.
|
|---|---|---|---|---|
|
Overall Survival
|
6.0 months
Interval 4.8 to 10.2
|
4.6 months
Interval 2.9 to 5.3
|
4.6 months
Interval 4.0 to 5.8
|
4.2 months
Interval 2.7 to 5.0
|
SECONDARY outcome
Timeframe: Disease assessment for response were performed every 6 weeks, up to 2 years.The number of confirmed and unconfirmed complete and partial responses in the subset of patients with measurable disease per RECIST 1.0. Estimated to within at least 17% (95% confidence interval). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept
n=41 Participants
Patients with platinum sensitive (complete response or partial response and \> 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
|
Platinum Sensitivity Treated With Topotecan Alone
n=39 Participants
Patients with platinum sensitivity treated with topotecan alone
|
Platinum Refractory Treated With Topotecan + Ziv-aflibercept
n=51 Participants
Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and \< 180 days for limited stage) treated topotecan and ziv-aflibercept.
|
Platinum Refractory Treated With Topotecan Aloine
n=48 Participants
Patients with platinum refractory treated topotecan alone.
|
|---|---|---|---|---|
|
Response Rate (Confirmed and Unconfirmed, Complete and Partial Responses)
|
0.02 proportion of participants
Interval 0.0 to 0.11
|
0 proportion of participants
Interval 0.0 to 0.07
|
0.02 proportion of participants
Interval 0.0 to 0.09
|
0 proportion of participants
Interval 0.0 to 0.06
|
SECONDARY outcome
Timeframe: Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.Population: Eligible patients who had received the protocol treatments were included in the adverse event summaries. Ant CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. The events listed here are not necessary to be included in Serious Adverse Event. A serious event could be death, life-threatening, hospitalization, disability or permanent damage, congenital anomaly...Grade 3 through 5 adverse event may not meet the criterion of serious adverse event.
Outcome measures
| Measure |
Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept
n=92 Participants
Patients with platinum sensitive (complete response or partial response and \> 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
|
Platinum Sensitivity Treated With Topotecan Alone
n=87 Participants
Patients with platinum sensitivity treated with topotecan alone
|
Platinum Refractory Treated With Topotecan + Ziv-aflibercept
Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and \< 180 days for limited stage) treated topotecan and ziv-aflibercept.
|
Platinum Refractory Treated With Topotecan Aloine
Patients with platinum refractory treated topotecan alone.
|
|---|---|---|---|---|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Bronchospasm, wheezing
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Cardiac-ischemia/infarction
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Colitis, infectious (e.g., Clostridium difficile)
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Diarrhea
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Dizziness
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Dyspnea (shortness of breath)
|
7 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Fatigue (asthenia, lethargy, malaise)
|
15 Participants
|
3 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Febrile neutropenia
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
GGT (gamma-glutamyl transpeptidase)
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Hemoglobin
|
9 Participants
|
7 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Hemorrhage, pulmonary/upper respiratory - Nose
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
INR (of prothrombin time)
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf (clin/microbio) w/Gr 3-4 neuts - Colon
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Infection with unknown ANC - Lung (pneumonia)
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Leukocytes (total WBC)
|
17 Participants
|
22 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Leukoencephalopathy (radiolographic findings)
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Lipase
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Lymphopenia
|
5 Participants
|
13 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Mucositis/stomatitis (clinical exam) - Oral cavity
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Muscle weakness, not d/t neuropathy - body/general
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Nausea
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Neutrophils/granulocytes (ANC/AGC)
|
30 Participants
|
23 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Abdomen NOS
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Chest wall
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Head/headache
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Pain NOS
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Platelets
|
29 Participants
|
17 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Pneumonitis/pulmonary infiltrates
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Potassium, serum-high (hyperkalemia)
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Potassium, serum-low (hypokalemia)
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Proteinuria
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Psychosis (hallucinations/delusions)
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Renal failure
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Seizure
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Sodium, serum-high (hypernatremia)
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Sodium, serum-low (hyponatremia)
|
6 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Syndromes-Other (Specify)
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Voice changes/dysarthria
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
AST, SGOT
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Anorexia
|
3 Participants
|
2 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Bilirubin (hyperbilirubinemia)
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Calcium, serum-high (hypercalcemia)
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Confusion
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Constipation
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Creatinine
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Dehydration
|
6 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Hemolysis
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Hemorrhage, GI - Upper GI NOS
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Hemorrhage, pulmo/upper resp- Bronchopulmonary NOS
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Hemorrhage, pulmonary/upper respiratory - Lung
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypertension
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Bronchus
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - UTI
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Infection with unknown ANC - Blood
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Left ventricular systolic dysfunction
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Thrombosis/thrombus/embolism
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Vomiting
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Weight loss
|
1 Participants
|
0 Participants
|
—
|
—
|
Adverse Events
Ziv-aflibercept + Topotecan
Serious events: 44 serious events
Other events: 91 other events
Deaths: 0 deaths
Topotecan
Serious events: 17 serious events
Other events: 86 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ziv-aflibercept + Topotecan
n=92 participants at risk
There are total 97 patients in this arm, but only 92 patients with measurable disease at baseline will be included in this analysis.
|
Topotecan
n=87 participants at risk
There are total 92 patients in this arm, but only 87 patients with measurable disease at baseline will be included in this analysis.
|
|---|---|---|
|
Investigations
GGT (gamma-glutamyl transpeptidase)
|
1.1%
1/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
4.3%
4/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Investigations
Platelets
|
8.7%
8/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.2%
2/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
1.1%
1/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.5%
6/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
2.2%
2/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
1.1%
1/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
3.3%
3/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general
|
3.3%
3/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
4.3%
4/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
1.1%
1/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death - Disease progression NOS
|
8.7%
8/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
9.2%
8/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor flare
|
1.1%
1/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Nervous system disorders
Dizziness
|
2.2%
2/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Nervous system disorders
Leukoencephalopathy (radiolographic findings)
|
1.1%
1/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Nervous system disorders
Pain - Head/headache
|
1.1%
1/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Nervous system disorders
Seizure
|
1.1%
1/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Psychiatric disorders
Confusion
|
4.3%
4/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
1.1%
1/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
6.5%
6/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
1.1%
1/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmo/upper resp- Bronchopulmonary NOS
|
1.1%
1/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Lung
|
1.1%
1/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
1.1%
1/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.1%
1/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
2.2%
2/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
1.1%
1/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
1.1%
1/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other
|
0.00%
0/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
1.1%
1/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Vascular disorders
Hypertension
|
1.1%
1/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
2.2%
2/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.1%
1/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
3.3%
3/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
1.1%
1/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Blood and lymphatic system disorders
Hemolysis
|
1.1%
1/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Cardiac disorders
Cardiac General-Other
|
0.00%
0/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
1.1%
1/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Cardiac disorders
Cardiac-ischemia/infarction
|
1.1%
1/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
1.1%
1/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Cardiac disorders
SVT and nodal arrhythmia - Atrial flutter
|
1.1%
1/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Cardiac disorders
SVT and nodal arrhythmia - Sinus tachycardia
|
2.2%
2/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Gastrointestinal disorders
Colitis
|
1.1%
1/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Gastrointestinal disorders
Hemorrhage, GI - Upper GI NOS
|
2.2%
2/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Gastrointestinal disorders
Nausea
|
2.2%
2/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.1%
1/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
General disorders
Death not associated with CTCAE term - Death NOS
|
6.5%
6/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
3.4%
3/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
5.4%
5/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
General disorders
Pain - Pain NOS
|
3.3%
3/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
General disorders
Syndromes-Other
|
1.1%
1/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Hepatobiliary disorders
Liver dysfunction/failure (clinical)
|
1.1%
1/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
1.1%
1/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
|
1.1%
1/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Catheter
|
1.1%
1/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
|
2.2%
2/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - UTI
|
0.00%
0/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
1.1%
1/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Infections and infestations
Infection with unknown ANC - Blood
|
0.00%
0/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
1.1%
1/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Infections and infestations
Infection with unknown ANC - Lung (pneumonia)
|
1.1%
1/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Investigations
AST, SGOT
|
1.1%
1/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
1.1%
1/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Investigations
Creatinine
|
1.1%
1/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
Other adverse events
| Measure |
Ziv-aflibercept + Topotecan
n=92 participants at risk
There are total 97 patients in this arm, but only 92 patients with measurable disease at baseline will be included in this analysis.
|
Topotecan
n=87 participants at risk
There are total 92 patients in this arm, but only 87 patients with measurable disease at baseline will be included in this analysis.
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
69.6%
64/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
74.7%
65/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Gastrointestinal disorders
Constipation
|
37.0%
34/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
35.6%
31/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Gastrointestinal disorders
Diarrhea
|
16.3%
15/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
16.1%
14/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Gastrointestinal disorders
Distention/bloating, abdominal
|
5.4%
5/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
2.3%
2/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
7.6%
7/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
4.6%
4/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
5.4%
5/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
5.7%
5/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symp) - Oral cav
|
6.5%
6/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
1.1%
1/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Gastrointestinal disorders
Nausea
|
37.0%
34/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
37.9%
33/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
14.1%
13/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
12.6%
11/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Gastrointestinal disorders
Pain - Stomach
|
5.4%
5/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Gastrointestinal disorders
Vomiting
|
15.2%
14/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
19.5%
17/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
General disorders
Edema: limb
|
7.6%
7/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
10.3%
9/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
70.7%
65/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
64.4%
56/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
General disorders
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
7.6%
7/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
4.6%
4/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
General disorders
Pain - Chest/thorax NOS
|
17.4%
16/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
13.8%
12/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
General disorders
Pain-Other
|
3.3%
3/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
8.0%
7/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
General disorders
Rigors/chills
|
8.7%
8/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
3.4%
3/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
13.0%
12/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
10.3%
9/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Investigations
AST, SGOT
|
15.2%
14/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
13.8%
12/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Investigations
Alkaline phosphatase
|
18.5%
17/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
16.1%
14/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Investigations
Creatinine
|
10.9%
10/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
14.9%
13/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Investigations
Leukocytes (total WBC)
|
56.5%
52/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
57.5%
50/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Investigations
Lymphopenia
|
17.4%
16/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
26.4%
23/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Investigations
Metabolic/Laboratory-Other
|
7.6%
7/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
8.0%
7/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
57.6%
53/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
48.3%
42/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Investigations
Platelets
|
76.1%
70/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
71.3%
62/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Investigations
Weight loss
|
25.0%
23/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
9.2%
8/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
23.9%
22/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
23.0%
20/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Metabolism and nutrition disorders
Anorexia
|
38.0%
35/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
32.2%
28/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
6.5%
6/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
0.00%
0/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
17.4%
16/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
13.8%
12/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Metabolism and nutrition disorders
Dehydration
|
9.8%
9/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
6.9%
6/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
29.3%
27/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
44.8%
39/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
20.7%
19/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
11.5%
10/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
15.2%
14/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
24.1%
21/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
28.3%
26/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
27.6%
24/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general
|
15.2%
14/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
8.0%
7/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
18.5%
17/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
19.5%
17/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
5.4%
5/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
3.4%
3/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
2.2%
2/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
6.9%
6/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
5.4%
5/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
10.3%
9/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Nervous system disorders
Dizziness
|
7.6%
7/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
18.4%
16/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Nervous system disorders
Neuropathy: sensory
|
8.7%
8/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
14.9%
13/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Nervous system disorders
Pain - Head/headache
|
19.6%
18/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
13.8%
12/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
6.5%
6/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
5.7%
5/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Psychiatric disorders
Confusion
|
5.4%
5/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
2.3%
2/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Psychiatric disorders
Insomnia
|
17.4%
16/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
17.2%
15/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Psychiatric disorders
Mood alteration - anxiety
|
8.7%
8/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
12.6%
11/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Psychiatric disorders
Mood alteration - depression
|
6.5%
6/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
6.9%
6/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Renal and urinary disorders
Proteinuria
|
8.7%
8/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
1.1%
1/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.3%
26/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
36.8%
32/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
41.3%
38/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
35.6%
31/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
10.9%
10/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
8.0%
7/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
17.4%
16/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
4.6%
4/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)
|
13.0%
12/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
21.8%
19/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Vascular disorders
Hypertension
|
25.0%
23/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
2.3%
2/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
|
Vascular disorders
Hypotension
|
4.3%
4/92 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
6.9%
6/87 • Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Only patients with measurable disease at baseline will be included in this analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60