PHASE-II TRIAL OF GEMCITABINE (2,2'-DIFLUORODEOXYCYTIDINE) IN PATIENTS WITH ADENOCARCINOMA OF THE PANCREAS

Gemcitabine is a novel nucleoside analog which demonstrated a broad sp ectrum of preclinical activity in solid tumor models, and responses in patients with pancreas cancer during phase I evaluation. Patients wit h measurable adenocarcinoma of the pancreas who had received no previo us chemotherapy were eligible for this multicenter phase II clinical t rial. Gemcitabine 800 mg/m(2) was administered intravenously weekly fo r 3 consecutive weeks, followed by one week rest, every 4 weeks. Forty -four patients entered the trial; 35 had at least 2 cycles of therapy. Partial response was observed in 5 patients (11%, estimated 95% confi dence interval 2-20%), with a median duration of 13 months. All respon ding patients had stabilization or improvement in performance status. Fourteen patients had stable disease of 4 or more months. The median W BC nadir was 3.8 x 10(3)/mu l (range 1.6-9.3) and the median absolute neutrophil (ANC) nadir was 2.0 x 10(3)/mu l (range 0.4-7.2). Thrombocy topenia - 100.0 x 10(3)/mu l was observed in 15 patients; the median p latelet nadir was 123.0 (range 30.0-245.0). All patients experienced a mild to moderate flu-like syndrome. In addition, one patient had a mi ld hemolytic-uremic syndrome which appeared related to gemcitabine the rapy. Gemcitabine demonstrated marginal activity in this resistant neo plasm, without excessive toxicity. Further evaluation, including the u se of more intense dosing and/or combination therapy, is warranted.