JPRN-UMIN000000896CompletedPhase 2
A combination phase II study of gemcitabine and S-1 for platinum-refractory patients with non-small cell lung cancer (TORG 0705) - A combination phase II study of gemcitabine and S-1 for platinum-refractory patients with non-small cell lung cancer (TORG 0705)
Thoracic Oncology Research Group0 sites32 target enrollmentStarted: December 1, 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 32
Study Overview
Brief Summary
Treatment was administered for median 4 courses (range 1 - 13) over a median 125-day period in 34 patients The overall response rate was 23.5% (no complete response and 8 partial response; 95% confidence interval: 9.1 - 38.0%). The median progression-free and overall survival times were 6.6 and 19.9 months, respectively. The 1- and 2-year survival rates were 58.8 and 30.9%, respectively. Toxicity was mild during the entire treatment period, except for 3 grade 3 interstitial pneumonia.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- ot applicable to ot applicable (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1) Any contraindication for S-1 or gemcitabine. 2) Active concomitant malignancy. 3) Active infectious diseases. 4) Prior resection of primary tumor. 5) Interstitial pneumonia obviously presented by x-ray and/or clinical manifestations. 6) Experience of any pulmonary event during the previous chemotherapy. 7) Prior chemotherapy including any primidine analogue such as 5-FU, tegafur, UFT, S-1, capecitabine, gemcitabine and Ara-C. 8) Brain metastasis with symptoms or requirement of treatment. 9) Requirement of thoracic irradiation. 10) Pleural effusion, ascites or pericardial effusion requiring treatment. 11) Serious abnormalty in ECG. 12) Uncontrolled diabetes mellitus. 13) Women in regnancy, potential pregnancy, or breast feeding. Men willing to cause pregnancy. 14) Other inadequate conditions .
Investigators
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