Phase II study of gemcitabine plus docetaxel in advanced pancreatic cancer: A Hoosier Oncology Group study

Objective: To determine the response rate, duration of response and survival with weekly gemcitabine plus docetaxel in metastatic or unresectable pancreatic cancer. Methods: Forty patients were enrolled, and 38 patients were evaluable for survival and toxicity. Thirtyseven patients were evaluable for response. Nine patients ( 24%) had locally advanced disease and 29 ( 76%) had metastatic disease at the time of enrollment. Median Eastern Cooperative Oncology Group performance status was 1. Patients received gemcitabine 750 mg/m(2) i. v. and docetaxel 35 mg/m(2) i. v. weekly for 3 out of 4 weeks for a maximum of 6 cycles. Results: Patients received a median of 4 cycles ( range 1 - 6) of chemotherapy. An objective response was obtained in 10 patients ( 27%) with a median duration of 17 weeks. Median survival was 7 months, and 1- year survival was 19.3%. Eight patients experienced at least one form of grade 4 toxicity and 27 patients experienced at least one type of grade 3 toxicity. Conclusions: The combination of gemcitabine and docetaxel is a well- tolerated regimen with clinical efficacy. The ultimate role of this combination versus single- agent gemcitabine can only be determined by a randomized phase III trial. Copyright (C) 2003 S. Karger AG, Basel.