Phase I/II trial of CPT-11 + S-1 combination therapy for patients with previously treated non-small cell lung cancer
- Conditions
- on-small cell lung cancer
- Registration Number
- JPRN-UMIN000001960
- Lead Sponsor
- Keio University School of Medicine Division of Pulmonary Medicine
- Brief Summary
Background This phase I study was conducted to evaluate the feasibility and to determine the recommended doses of the combination therapy of S-1 and irinotecan (CPT-11) in patients with advanced non-small cell lung cancer (NSCLC) as second-line treatment. Methods Patients with NSCLC who were previously treated with one chemotherapy regimen and had a performance status of 0 or 1 were eligible. CPT-11 was administered at 60 mg/m2 (level 1), 80 mg/m2 (level 2) on days 1 and 8, and oral S-1 was administered at 80 mg/day for body surface area (BSA) less than 1.25 m2, 100 mg/day for BSA 1.25-1.5 m2, and 120 mg/day for BSA more than 1.5 m2 on days 1-14 every 3 weeks. The dose-limiting toxicity (DLT) was defined as grade 4 leukocytopenia or neutropenia, grade >=3 neutropenia with fever over 38degree, grade >=3 thrombocytopenia, or grade >=3 major nonhematological toxicities. Results Nine patients were enrolled in the study. None of 3 patients enrolled in level 1 had any DLT. Of 6 patients in level 2, 2 patients had grade 3 diarrhea and one had grade 3 interstitial pneumonia. Level 1 was declared as the recommended dose. Conclusion The feasibility of the combination therapy of S-1 and CPT-11 was shown in the second-line setting for the treatment of advanced NSCLC. The recommended dose of CPT-11 was 60 mg/m2 combined with standard dose of S-1 for phase II trials of pretreated advanced NSCLC patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 36
Not provided
1) Patients with infections 2) Patients with massive pleural or pericardial effusion ,or ascites 3) Patients with pulmonary fibrosis interstitial pneumonia 4) Patients with diarrhea 5) Patients with intestinal paralysis or intestinal obstruction 6) Patients clinically important heart disease 7) Patients with significant complications 8) Patients with pregnancy or lactation 9) Patients with active concomitant malignancy 10) Patients with symptomatic brain metastasis 11) Patients in the administration of flucytosine (12) Patients in the administration of atazanavir sulfate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Anticancer efficacy
- Secondary Outcome Measures
Name Time Method Duration of effect, Progression free survival, overall survival (Median survival time, 1-year survival rate), Adverse events.