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 antica ncer agent with activity in preclinical models, was felt to be a promi sing new chemotherapy drug which warranted testing in patients with ad vanced renal cell carcinoma. Methods: Eighteen patients with histologi cally 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 da y treatment cycle. Initial doses of gemcitabine were 800 mg/m2; doses in subsequent cycles were escalated to a maximum of 1250 mg/M2, toxici ty permitting. Results: One partial response was seen for a response r ate of 6%. Hematologic toxicity was not severe with this dosing schedu le; however, two patients developed dyspnea with bronchospasm after re peated injections of drug. Conclusions: The dose and schedule of gemci tabine employed results in only a modest response rate in patients wit h advanced renal carcinoma. Investigators should be aware of the possi bility of dyspnea and bronchospasm developing shortly after gemcitabin e administration.