Phase II trial of capecitabine and weekly docetaxel in metastatic renal cell carcinoma.

OBJECTIVES: To evaluate the toxicity and efficacy of capecitabine and weekly docetaxel in a phase II clinical trial.
METHODS: Eligibility included metastatic renal cancer with a maximum of 2 prior regimens, performance status of 0-2, and adequate renal, hepatic, and bone marrow function. Docetaxel was administered intravenously at a dose of 36 mg/m(2) weekly on days 1, 8, and 15 of a 28- day cycle and capecitabine was administered orally at a dose of 1800 mg/m(2) from days 5-18. Toxicity was assessed on days 1, 8, and 15 of each cycle, and response was evaluated every 2 cycles.
RESULTS: Twenty-five patients, 19 white and 6 African American, were enrolled on this phase II trial. The median age was 60 years (range: 39-75 years). Eighteen patients had clear cell histology, 7 had papillary, sarcomatoid, or chromophobe histology. Thirteen had liver/bone metastases and 13 had >or=2 of the Memorial Sloan-Kettering Cancer Center prognostic risk factors. Twelve patients received prior immunotherapy. A total of 93 cycles were administered; median of 3 cycles and range from 0-10 cycles. The therapy was well tolerated. No treatment-related mortality was observed and 2 treatment-related hospitalizations for nausea, diarrhea, and dehydration occurred. Ten patients had stable disease. The median time to progression was 1.7 months and median survival was 11.1 months.
CONCLUSIONS: The combination of capecitabine and docetaxel was well tolerated in metastatic renal cancer. Clinical activity was predominantly noted in non-clear cell histology in which chemotherapy would be worthy of future investigation.