Phase II study of gemcitabine in combination with cisplatin in patients with locally advanced and/or metastatic pancreatic cancer

The present phase II trial was performed to assess the efficacy and toxicit y of polychemotherapy with gemcitabine and cisplatin in patients with local ly advanced or metastatic carcinoma of the pancreas. Sixteen patients recei ved six courses of an i.v. cytotoxic regimen consisting of gemcitabine (100 0 mg/m(2), days 1, 8 and 15) and cisplatin (35 mg/m(2), days 1, 8 and 15) a dministered in 28-day intervals, Complete remission (CR) occurred in one pa tient (6%), partial remission (PR) in four patients (25%) and stable diseas e in seven patients (44%), whereas four patients (25%) developed progressiv e disease resulting in an overall response rate of 31%. Mean duration of re sponses (CR+PR) was 3.6 (range 0.7-8.5) months and mean time to progression was 7.4 (range 3.8-12.6) months, After a mean observation period of 11.5 m onths the overall survival was 9.6 months with 12 patients (75%) still bein g alive, which compares favorably with historical data of the administratio n of gemcitabine alone. The performance status improved in three (19%) and stabilized in eight (50%) out of 16 patients for 4 weeks or longer. Treatme nt-associated toxicity Included alopecia of WHO grade III in all cases, leu kopenia of WHO grades 1 and II in 10 patients (63%), grade III in five pati ents (31%), and thrombocytopenia grades I and II in four patients (25%), an d grades III and IV in 10 patients (63%), We conclude that the administered dosage and schedule of gemcitabine and cisplatin in patients with locally advanced or metastatic cancer of the pancreas constitutes an active cytotox ic regimen associated with moderate toxicity. [(C) 2000 Lippincott Williams & Wilkins.].