A phase II study of gemcitabine (G) and capecitabine (C) in patients with metastatic renal cell cancer (mRCC): A report of Cancer and Leukemia Group B #90008

Publisher Website
Google Scholar
Abstract
4515 Background: Low but consistent responses have been observed in mRCC patients (pts) treated with 5FU, G, or the combination. A phase II multi-center study to assess the activity of G plus the oral 5FU analog C was thus conducted. Methods: Pts with adequate performance status (PS), normal organ function, measurable disease, and no prior nucleoside analog therapy were treated with G at 1000 mg/m2 day 1, 8, 15 and C at 830 mg/m2 twice daily, days 1–21 on a 28 day cycle. Dose reductions for estimated creatinine clearance of 30–50 ml/min, hand/foot syndrome, myelosuppression, hepatic toxicity, and gastrointestinal toxicity were specified. A null hypothesis of a 5% response rate versus an alternative of 15% was assumed, with type I and type II error rates of 7% and 14%, respectively. Results: Sixty pts from 18 institutions were accrued over 19 weeks. In 55 pts with complete data, characteristics included PS 0/1/2 in 20/27/8, prior nephrectomy in 45, prior systemic therapy in 42, greater than 2 metastatic si...

This publication has 0 references indexed in Scilit: