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.

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/m(2) day 1, 8, 15 and C at 830 mg/m(2) 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 sites in 23, median and interquartile hemoglobin of 12.4 (10.3 -14.5) g/dl. Partial responses were observed in 8 out of 55 pts for a response rate of 15% (95% CI: 7 -27%). Median duration of response was 7.1 (4.0 -7.1) months (mo). Median time to progression was 5.1 (3.2 -7.8) mo. With a median follow-up of 5.5 mo, median survival has not been reached. Grade 3,4 toxicities included neutropenia (40%) with febrile neutropenia in 1 pt, anemia (15%), thrombocytopenia (6%), nausea (11%), fatigue (7%), diarrhea (7%), and hand/foot syndrome and stomatitis (2% each). Grade 1,2 toxicities included leukopenia (49%), fatigue (62%), nausea (42%), stomatitis (29%), diarrhea (27%), and hand/foot syndrome (36%). CONCLUSIONS: GC has modest activity in mRCC and met the protocol specified level of activity for further evaluation. Toxicity suggests that additional study of this regimen would require a dose modification. [Table: see text].

Duke Scholars

Author Susan Halabi Biostatistics & Bioinformatics, Division of Biostatistics