Trial Outcomes & Findings for Topotecan and Carboplatin in the First-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer (NCT NCT00305942)
NCT ID: NCT00305942
Last Updated: 2013-01-31
Results Overview
Overall response rate is the percent of patients experiencing a complete or partial response by RECIST v. 1 Criteria. Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. The final response category assigned represented the best response obtained during treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
18 months
Results posted on
2013-01-31
Participant Flow
Participant milestones
| Measure |
Topotecan/Carboplatin
Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for \> 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
|
|---|---|
|
Overall Study
STARTED
|
61
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
38
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Topotecan and Carboplatin in the First-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Topotecan/Carboplatin
n=61 Participants
Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for \> 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
37 Participants
n=93 Participants
|
|
Age Continuous
|
66 years
STANDARD_DEVIATION 9.8 • n=93 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: All patients were included in the analysis.
Overall response rate is the percent of patients experiencing a complete or partial response by RECIST v. 1 Criteria. Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. The final response category assigned represented the best response obtained during treatment.
Outcome measures
| Measure |
Topotecan/Carboplatin
n=61 Participants
Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for \> 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
|
|---|---|
|
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
|
57 percentage of participants
Interval 44.0 to 70.0
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: All patients were assessed for time to progression.
Time to progression is defined as the interval between the start date of treatment and the date of occurrence of progressive disease.
Outcome measures
| Measure |
Topotecan/Carboplatin
n=61 Participants
Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for \> 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
|
|---|---|
|
Time to Progression (TTP), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease
|
5.5 Months
Interval 4.0 to 6.3
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: All patients were assessed for overall survival.
Overall survival was measured from the date of study entry until the date of death.
Outcome measures
| Measure |
Topotecan/Carboplatin
n=61 Participants
Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for \> 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
|
|---|---|
|
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
|
8.5 Months
Interval 7.2 to 11.4
|
Adverse Events
Topotecan/Carboplatin
Serious events: 28 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Topotecan/Carboplatin
n=61 participants at risk
Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for \> 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
|
|---|---|
|
Cardiac disorders
Cardiac ischemia/infarction
|
1.6%
1/61 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
1.6%
1/61 • Number of events 1
|
|
Cardiac disorders
Conduction abnormality - Asystole
|
1.6%
1/61 • Number of events 1
|
|
Nervous system disorders
Confusion
|
1.6%
1/61 • Number of events 1
|
|
General disorders
Death not associated with CTCAE term - Disease Progression NOS
|
9.8%
6/61 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Febrile Neutropenia
|
3.3%
2/61 • Number of events 2
|
|
General disorders
Fever (NOS)
|
1.6%
1/61 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
1.6%
1/61 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Gastroenteritis)
|
1.6%
1/61 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Perforated diverticulum)
|
1.6%
1/61 • Number of events 1
|
|
Blood and lymphatic system disorders
Hematoma
|
1.6%
1/61 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin
|
4.9%
3/61 • Number of events 3
|
|
Blood and lymphatic system disorders
Hemorrhage, GI
|
1.6%
1/61 • Number of events 1
|
|
Cardiac disorders
Hypotension
|
1.6%
1/61 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemia
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Infection - Other (Cellulitis)
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Infection - Other (Pneumonia)
|
3.3%
2/61 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutrophils
|
1.6%
1/61 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain - back
|
1.6%
1/61 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pain - chest
|
1.6%
1/61 • Number of events 1
|
|
Blood and lymphatic system disorders
Pancytopenia (NOS)
|
3.3%
2/61 • Number of events 2
|
|
Blood and lymphatic system disorders
Platelets
|
4.9%
3/61 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.6%
1/61 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Respiratory Failure)
|
1.6%
1/61 • Number of events 1
|
|
Nervous system disorders
Seizure
|
1.6%
1/61 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
1/61 • Number of events 1
|
Other adverse events
| Measure |
Topotecan/Carboplatin
n=61 participants at risk
Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for \> 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
|
|---|---|
|
Metabolism and nutrition disorders
Alkaline Phospahatase
|
24.6%
15/61 • Number of events 26
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
23.0%
14/61 • Number of events 38
|
|
Metabolism and nutrition disorders
ALT, SGPT
|
9.8%
6/61 • Number of events 9
|
|
Gastrointestinal disorders
Anorexia
|
36.1%
22/61 • Number of events 50
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.4%
10/61 • Number of events 19
|
|
Metabolism and nutrition disorders
AST, SGOT
|
14.8%
9/61 • Number of events 11
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow-Other
|
26.2%
16/61 • Number of events 26
|
|
Cardiac disorders
Cardiac-Other
|
6.6%
4/61 • Number of events 5
|
|
Nervous system disorders
Confusion
|
8.2%
5/61 • Number of events 7
|
|
Gastrointestinal disorders
Constipation
|
42.6%
26/61 • Number of events 70
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
31.1%
19/61 • Number of events 27
|
|
Gastrointestinal disorders
Dehydration
|
16.4%
10/61 • Number of events 18
|
|
Gastrointestinal disorders
Diarrhea
|
26.2%
16/61 • Number of events 20
|
|
Nervous system disorders
Dizziness
|
9.8%
6/61 • Number of events 10
|
|
Gastrointestinal disorders
Dysphagia
|
6.6%
4/61 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
45.9%
28/61 • Number of events 52
|
|
Blood and lymphatic system disorders
Edema
|
18.0%
11/61 • Number of events 23
|
|
General disorders
Fatigue
|
85.2%
52/61 • Number of events 184
|
|
Infections and infestations
Febrile Neutropenia
|
9.8%
6/61 • Number of events 7
|
|
General disorders
Fever
|
6.6%
4/61 • Number of events 5
|
|
Blood and lymphatic system disorders
Hemoglobin
|
86.9%
53/61 • Number of events 200
|
|
Vascular disorders
Hemorrhage (Lung)
|
6.6%
4/61 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
36.1%
22/61 • Number of events 36
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
18.0%
11/61 • Number of events 22
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.5%
7/61 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.8%
9/61 • Number of events 10
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.8%
9/61 • Number of events 11
|
|
Cardiac disorders
Hypotension
|
13.1%
8/61 • Number of events 11
|
|
Infections and infestations
Infection (Lung-Pneumonia)
|
9.8%
6/61 • Number of events 7
|
|
Infections and infestations
Infection (Urinary Tract-NOS)
|
8.2%
5/61 • Number of events 6
|
|
General disorders
Insomnia
|
18.0%
11/61 • Number of events 15
|
|
Blood and lymphatic system disorders
Leukocytes (WBC)
|
75.4%
46/61 • Number of events 89
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other
|
16.4%
10/61 • Number of events 12
|
|
Nervous system disorders
Mood Alteration (anxiety)
|
9.8%
6/61 • Number of events 6
|
|
Nervous system disorders
Mood Alteration (Depression)
|
13.1%
8/61 • Number of events 12
|
|
Gastrointestinal disorders
Mucositis
|
8.2%
5/61 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.8%
6/61 • Number of events 12
|
|
Gastrointestinal disorders
Nausea
|
42.6%
26/61 • Number of events 50
|
|
Blood and lymphatic system disorders
Neutrophils (ANC/AGC)
|
86.9%
53/61 • Number of events 156
|
|
General disorders
Pain
|
65.6%
40/61 • Number of events 96
|
|
Gastrointestinal disorders
Pain (Abdomen-NOS)
|
9.8%
6/61 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Pain (back)
|
21.3%
13/61 • Number of events 19
|
|
Musculoskeletal and connective tissue disorders
Pain (bone)
|
21.3%
13/61 • Number of events 27
|
|
Respiratory, thoracic and mediastinal disorders
Pain (chest/thorax-NOS)
|
18.0%
11/61 • Number of events 20
|
|
Musculoskeletal and connective tissue disorders
Pain (extremity-limb)
|
6.6%
4/61 • Number of events 7
|
|
Nervous system disorders
Pain (headache)
|
8.2%
5/61 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Pain (joint)
|
11.5%
7/61 • Number of events 11
|
|
General disorders
Pain (NOS)
|
16.4%
10/61 • Number of events 13
|
|
Blood and lymphatic system disorders
Platelets
|
82.0%
50/61 • Number of events 150
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
36.1%
22/61 • Number of events 41
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other
|
6.6%
4/61 • Number of events 7
|
|
Nervous system disorders
Sensory Neuropathy
|
8.2%
5/61 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Skin
|
19.7%
12/61 • Number of events 14
|
|
Gastrointestinal disorders
Taste Alteration
|
6.6%
4/61 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes/Dysarthria
|
11.5%
7/61 • Number of events 8
|
|
Gastrointestinal disorders
Vomiting
|
26.2%
16/61 • Number of events 23
|
|
General disorders
Weight Loss
|
19.7%
12/61 • Number of events 23
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
8.2%
5/61 • Number of events 5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
- Publication restrictions are in place
Restriction type: OTHER