Trial Outcomes & Findings for Irinotecan and Carboplatin in Treating Patients With Metastatic or Recurrent Small Cell Lung Cancer (NCT NCT00387660)
NCT ID: NCT00387660
Last Updated: 2018-01-10
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by radiographic techniques. 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.
COMPLETED
PHASE2
80 participants
Up to 36 months
2018-01-10
Participant Flow
The recruitment period was 6 years. Subjects were recruited at 4 large medical centers.
Participant milestones
| Measure |
Arm A - Metastatic SCLC (no Previous Chemo)
Extensive small cell lung cancer with no previous chemotherapy
|
Arm B - Relapsed SCLC (Previous Chemo)
Relapsed small cell lung cancer with previous chemotherapy
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Irinotecan and Carboplatin in Treating Patients With Metastatic or Recurrent Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm A
n=40 Participants
Metastatic small cell lung cancer with no previous chemotherapy
|
Arm B
n=40 Participants
Relapsed small cell lung cancer with previous chemotherapy
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
n=93 Participants
|
65 years
n=4 Participants
|
65 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=93 Participants
|
40 participants
n=4 Participants
|
80 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Up to 36 monthsPopulation: All participants for whom response evaluation measurements were recorded at Baseline and after 2 cycles.
Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by radiographic techniques. 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 |
Arm A
n=34 Participants
Irinotecan (200 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
|
Arm B
n=38 Participants
Irinotecan (150 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
|
|---|---|---|
|
Overall Response Rate
|
65 percentage of participants
|
50 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: All participants for whom response evaluation measurements were recorded at Baseline and after 2 cycles.
The length of time from the start of treatment that half of the patients in a group of patients diagnosed with the disease are still alive.
Outcome measures
| Measure |
Arm A
n=34 Participants
Irinotecan (200 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
|
Arm B
n=38 Participants
Irinotecan (150 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
|
|---|---|---|
|
Median Survival of Patients Treated With This Regimen
|
10 months
Interval 6.0 to 14.0
|
10 months
Interval 6.0 to 14.0
|
SECONDARY outcome
Timeframe: Up to 36 monthsAll adverse events were graded according to the National Cancer InstituteCommon Toxicity Criteria, version 2.0. All 80 patients were assessable for toxicity at least for the first cycle.
Outcome measures
| Measure |
Arm A
n=40 Participants
Irinotecan (200 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
|
Arm B
n=40 Participants
Irinotecan (150 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
|
|---|---|---|
|
Number of Participants With Toxicity
|
40 Participants
|
40 Participants
|
Adverse Events
Arm A
Arm B
Serious adverse events
| Measure |
Arm A
n=40 participants at risk
Irinotecan (200 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
|
Arm B
n=40 participants at risk
Irinotecan (150 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.5%
1/40 • Up to 36 months
|
0.00%
0/40 • Up to 36 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/40 • Up to 36 months
|
2.5%
1/40 • Up to 36 months
|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • Up to 36 months
|
2.5%
1/40 • Up to 36 months
|
Other adverse events
| Measure |
Arm A
n=40 participants at risk
Irinotecan (200 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
|
Arm B
n=40 participants at risk
Irinotecan (150 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
52.5%
21/40 • Up to 36 months
|
55.0%
22/40 • Up to 36 months
|
|
Blood and lymphatic system disorders
Neutropenic fever
|
10.0%
4/40 • Up to 36 months
|
2.5%
1/40 • Up to 36 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.0%
8/40 • Up to 36 months
|
22.5%
9/40 • Up to 36 months
|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
4/40 • Up to 36 months
|
15.0%
6/40 • Up to 36 months
|
|
Gastrointestinal disorders
Diarrhea
|
22.5%
9/40 • Up to 36 months
|
20.0%
8/40 • Up to 36 months
|
|
Gastrointestinal disorders
Nausea/emesis
|
7.5%
3/40 • Up to 36 months
|
12.5%
5/40 • Up to 36 months
|
|
Infections and infestations
Treatment-related death
|
5.0%
2/40 • Up to 36 months
|
2.5%
1/40 • Up to 36 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place