Phase I/II study of TS-1 and CBDCA combination chemotherapy in elderly patients with advanced non-small-cell lung cancer
- Conditions
- Advanced non-small-cell lung cancer in elderly patients
- Registration Number
- JPRN-UMIN000007049
- Lead Sponsor
- The Tokyo Cooperative Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 35
Not provided
1)Patients with interstitial pneumonia or pulmonary fibrosis on Chest X-ray 2)Patients with pleural or pericardial effusion ,or ascites 3) Patients with active double cancer 4)Patients with significant complications a) Uncontrolled angina pectoris, myocardial infarction, heart failure within 3 months b)Uncontrolled diabetes or hypertension c)Current severe infection, or suspicious of severe infection d) Patients whose participation in the trial is judged to be inappropriate by the attending doctor. (e.g., ileus, bleeding tendency, diarrhea and varicella) 5)Patients with symptomatic brain metastasis 6)Patients with pregnancy or lactation 7) History of serious drug allergy 8) History of serious allergic reaction with CBDCA or other platinum-containing drug 9) History of serious allergic reaction with S-1 10) Being treated with other pyrimidine fluoride antineoplastic agents. 11) Being treated with flucytosine. 12) Any patients judged by the investigator to be unfit to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I study: MTD, RD Phase II study : Response rate in RD
- Secondary Outcome Measures
Name Time Method Phase I study: Safety Phase II study : OS, PFS and Safety