GEMCITABINE IN ADVANCED RENAL-CELL CARCINOMA - A PHASE-II STUDY OF THE NATIONAL-CANCER-INSTITUTE OF CANADA-CLINICAL-TRIALS-GROUP

Background: Gemcitabine (2', 2'-difluorodeoxycytidine; dFdC) an anticancer agent with activity in preclinical models, was felt to be a promising new chemotherapy drug which warranted testing in patients with advanced renal cell carcinoma. Methods: Eighteen patients with histologically proven metastatic or locally recurrent renal cell carcinoma and bidimensionally measurable disease were accrued to a phase II study of gemcitabine administered intravenously on days 1, 8 and 15 of a 28 day treatment cycle. Initial doses of gemcitabine were 800 mg/m2; doses in subsequent cycles were escalated to a maximum of 1250 mg/M2, toxicity permitting. Results: One partial response was seen for a response rate of 6%. Hematologic toxicity was not severe with this dosing schedule; however, two patients developed dyspnea with bronchospasm after repeated injections of drug. Conclusions: The dose and schedule of gemcitabine employed results in only a modest response rate in patients with advanced renal carcinoma. Investigators should be aware of the possibility of dyspnea and bronchospasm developing shortly after gemcitabine administration.