Trial Outcomes & Findings for Ziv-Aflibercept in Treating Patients With Metastatic or Unresectable Kidney Cancer (NCT NCT00357760)
NCT ID: NCT00357760
Last Updated: 2017-06-23
Results Overview
Progression-free survival (PFS) was defined as time from randomization to the earlier of documentation of progression or death. The proportion of patients who are progression-free and alive at 8 weeks was estimated using the Kaplan-Meier method and the confidence interval was estimated using log transformation method. Progression is defined using Response Evaluation Criteria In Solid Tumors (RECIST), as a 20% increase in the sum of the longest diameters of target lesions, or the appearance of new lesions, or unequivocal progression of existing nontarget lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
94 participants
Primary outcome timeframe
Assessed at 8 weeks
Results posted on
2017-06-23
Participant Flow
The study was activated on 12/21/2007 and closed to accrual on 12/6/2013 with a total accrual of 94 patients.
Participant milestones
| Measure |
Arm A (Higher Dose of VEGF Trap)
Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Lower Dose of VEGF Trap)
Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
35
|
|
Overall Study
Patients Who Started Treatment
|
57
|
34
|
|
Overall Study
Eligible and Treated Patients
|
57
|
32
|
|
Overall Study
Patients Who Undergo Dose Escalation
|
0
|
16
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
59
|
35
|
Reasons for withdrawal
| Measure |
Arm A (Higher Dose of VEGF Trap)
Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Lower Dose of VEGF Trap)
Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.
|
|---|---|---|
|
Overall Study
Disease progression
|
44
|
17
|
|
Overall Study
Adverse Event
|
10
|
7
|
|
Overall Study
Death
|
0
|
3
|
|
Overall Study
Alternative therapy
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Never started treatment
|
2
|
1
|
|
Overall Study
Ineligible
|
0
|
2
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
To receive hospice care
|
0
|
1
|
Baseline Characteristics
Ziv-Aflibercept in Treating Patients With Metastatic or Unresectable Kidney Cancer
Baseline characteristics by cohort
| Measure |
Arm A (Higher Dose of VEGF Trap)
n=57 Participants
Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Lower Dose of VEGF Trap)
n=32 Participants
Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
62 years
n=7 Participants
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at 8 weeksPopulation: Eligible and treated patients are included in this analysis.
Progression-free survival (PFS) was defined as time from randomization to the earlier of documentation of progression or death. The proportion of patients who are progression-free and alive at 8 weeks was estimated using the Kaplan-Meier method and the confidence interval was estimated using log transformation method. Progression is defined using Response Evaluation Criteria In Solid Tumors (RECIST), as a 20% increase in the sum of the longest diameters of target lesions, or the appearance of new lesions, or unequivocal progression of existing nontarget lesions.
Outcome measures
| Measure |
Arm A (Higher Dose of VEGF Trap)
n=57 Participants
Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Lower Dose of VEGF Trap)
n=32 Participants
Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.
|
|---|---|---|
|
Proportion of Patients Alive and Progression-free at 8 Weeks
|
0.70 proportion of participants
Interval 0.59 to 0.79
|
0.52 proportion of participants
Interval 0.37 to 0.66
|
SECONDARY outcome
Timeframe: Assessed every 8 weeks while on treatment and then every 3 months until patient is 2 years from enrollment, and then every 6 months until patient is 3 years from enrollmentPopulation: Eligible and treated patients are included in this analysis.
Objective response is defined as complete response (CR) or partial response (PR) determined by Solid Tumor Response Criteria (RECIST). CR: The disappearance of all target lesions without the appearance of new lesion(s) and/or unequivocal progression of existing non-target lesions. PR: At least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter without the appearance of new lesion(s) and/or unequivocal progression of existing non-target lesions. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met.
Outcome measures
| Measure |
Arm A (Higher Dose of VEGF Trap)
n=57 Participants
Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Lower Dose of VEGF Trap)
n=32 Participants
Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.
|
|---|---|---|
|
Proportion of Patients With Objective Response
|
0.053 proportion of participants
Interval 0.014 to 0.13
|
0.031 proportion of participants
Interval 0.002 to 0.14
|
SECONDARY outcome
Timeframe: Assessed every 8 weeks while on treatment and then every 3 months until patient is 2 years from enrollment, and then every 6 months until patient is 3 years from enrollmentPopulation: Only patients who progressed on the low dose (Arm B) and underwent dose escalation were included in this analysis.
Patients who progressed on the 1 mg/kg dose (Arm B) at 8 weeks would have the opportunity to receive the 4 mg/kg dose. PFS is defined as the time from dose escalation to disease progression or death, whichever occurs first. Disease progression is defined using Response Evaluation Criteria In Solid Tumors (RECIST), as a 20% increase in the sum of the longest diameters of target lesions, or the appearance of new lesions, or unequivocal progression of existing nontarget lesions.
Outcome measures
| Measure |
Arm A (Higher Dose of VEGF Trap)
Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Lower Dose of VEGF Trap)
n=16 Participants
Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.
|
|---|---|---|
|
Progression-free Survival (PFS) Among Patients Who Undergo Dose Escalation Following Progression on Lower-dose VEGF Trap
|
—
|
14.57 weeks
Interval 7.57 to 33.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed at baseline, 4 weeks, 6 weeks, 8 weeks and end of treatmentOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed every 8 weeks during treatment and end of treatmentOutcome measures
Outcome data not reported
Adverse Events
Arm A (Higher Dose of VEGF Trap)
Serious events: 35 serious events
Other events: 52 other events
Deaths: 0 deaths
Arm B (Lower Dose of VEGF Trap)
Serious events: 18 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (Higher Dose of VEGF Trap)
n=57 participants at risk
Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Lower Dose of VEGF Trap)
n=34 participants at risk
Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.5%
2/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
8.8%
3/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
2.9%
1/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Cardiac disorders
Cardiac-ischemia
|
1.8%
1/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
0.00%
0/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Investigations
Cardiac troponin I (cTnI) increased
|
0.00%
0/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
2.9%
1/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Vascular disorders
Hypertension
|
35.1%
20/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
14.7%
5/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Vascular disorders
Hypotension
|
1.8%
1/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
0.00%
0/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
1.8%
1/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
0.00%
0/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
General disorders
Fatigue
|
3.5%
2/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
20.6%
7/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
1.8%
1/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
0.00%
0/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
2.9%
1/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Nervous system disorders
CNS, hemorrhage
|
0.00%
0/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
2.9%
1/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Renal and urinary disorders
Urinary hemorrhage NOS
|
0.00%
0/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
2.9%
1/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Infections and infestations
Infection Gr0-2 neut, urinary tract
|
1.8%
1/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
0.00%
0/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
2.9%
1/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Renal and urinary disorders
Glomerular filtration rate decreased
|
0.00%
0/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
2.9%
1/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
2.9%
1/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.8%
1/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
0.00%
0/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Renal and urinary disorders
Proteinuria
|
15.8%
9/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
5.9%
2/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.5%
2/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
0.00%
0/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Nervous system disorders
Cognitive disturbance
|
1.8%
1/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
0.00%
0/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Nervous system disorders
Encephalopathy
|
1.8%
1/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
0.00%
0/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Gastrointestinal disorders
Abdomen, pain
|
3.5%
2/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
0.00%
0/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
0.00%
0/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
2.9%
1/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone, pain
|
0.00%
0/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
2.9%
1/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Nervous system disorders
Head/headache
|
3.5%
2/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
0.00%
0/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
0.00%
0/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
2.9%
1/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.3%
3/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
2.9%
1/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Renal and urinary disorders
Renal/GU-other
|
0.00%
0/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
2.9%
1/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Immune system disorders
Cytokine release syndrome
|
1.8%
1/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
0.00%
0/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
5.3%
3/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
0.00%
0/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
Other adverse events
| Measure |
Arm A (Higher Dose of VEGF Trap)
n=57 participants at risk
Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Lower Dose of VEGF Trap)
n=34 participants at risk
Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.3%
3/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
2.9%
1/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
19.3%
11/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
32.4%
11/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Blood and lymphatic system disorders
Hemolysis
|
8.8%
5/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
0.00%
0/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Investigations
Leukocytes decreased
|
8.8%
5/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
2.9%
1/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Investigations
Neutrophils decreased
|
3.5%
2/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
5.9%
2/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Investigations
Platelets decreased
|
8.8%
5/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
8.8%
3/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Vascular disorders
Hypertension
|
38.6%
22/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
29.4%
10/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
General disorders
Fatigue
|
63.2%
36/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
70.6%
24/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
General disorders
Fever w/o neutropenia
|
1.8%
1/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
5.9%
2/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
General disorders
Rigors/chills
|
0.00%
0/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
8.8%
3/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Skin and subcutaneous tissue disorders
Sweating
|
3.5%
2/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
5.9%
2/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Investigations
Weight loss
|
12.3%
7/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
11.8%
4/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.3%
3/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
2.9%
1/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
7.0%
4/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
5.9%
2/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
5.3%
3/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
2.9%
1/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
38.6%
22/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
47.1%
16/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
19.3%
11/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
29.4%
10/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
19.3%
11/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
23.5%
8/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Gastrointestinal disorders
Dry mouth
|
7.0%
4/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
2.9%
1/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Gastrointestinal disorders
Dyspepsia
|
1.8%
1/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
5.9%
2/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
0.00%
0/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
11.8%
4/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
8.8%
5/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
17.6%
6/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
19.3%
11/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
50.0%
17/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Nervous system disorders
Taste disturbance
|
7.0%
4/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
8.8%
3/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
1/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
17.6%
6/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nose, hemorrhage
|
5.3%
3/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
17.6%
6/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleura, hemorrhage
|
7.0%
4/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
5.9%
2/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
General disorders
Edema limb
|
7.0%
4/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
14.7%
5/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.5%
6/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
5.9%
2/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Investigations
Alkaline phosphatase increased
|
7.0%
4/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
14.7%
5/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Investigations
Alanine aminotransferase increased
|
10.5%
6/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
2.9%
1/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
7.0%
4/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
8.8%
3/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
8.8%
3/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.5%
2/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
5.9%
2/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Investigations
Creatinine increased
|
14.0%
8/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
17.6%
6/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.3%
3/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
14.7%
5/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.0%
4/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
2.9%
1/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.5%
2/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
11.8%
4/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Renal and urinary disorders
Proteinuria
|
43.9%
25/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
58.8%
20/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.3%
7/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
20.6%
7/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Nervous system disorders
Dizziness
|
8.8%
5/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
2.9%
1/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
5.9%
2/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Nervous system disorders
Neuropathy-sensory
|
3.5%
2/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
11.8%
4/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Gastrointestinal disorders
Abdomen, pain
|
0.00%
0/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
5.9%
2/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
0.00%
0/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
8.8%
3/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
General disorders
Chest/thoracic pain NOS
|
3.5%
2/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
8.8%
3/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
0.00%
0/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
5.9%
2/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Nervous system disorders
Head/headache
|
29.8%
17/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
23.5%
8/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
19.3%
11/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
23.5%
8/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
7.0%
4/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
8.8%
3/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
General disorders
Pain-other
|
8.8%
5/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
0.00%
0/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.0%
8/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
17.6%
6/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.0%
8/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
35.3%
12/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reaction
|
7.0%
4/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
0.00%
0/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
21.1%
12/57 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
29.4%
10/34 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, assessed up to 3 years
|
Additional Information
Study Statistician
ECOG-ACRIN Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60