A randomized phase II study of gemcitabine/cisplatin, gemcitabine fixed dose rate infusion, gemcitabine/docetaxel, or gemcitabine/irinotecan in patients with metastatic pancreatic cancer (CALGB 89904).
4011 Background: In the treatment of advanced pancreatic cancer, chemotherapy regimens utilizing prolonged infusions of gemcitabine or combinations of gemcitabine and other agents have been associated with higher objective tumor response rates and, in some cases, improvements in progression-free survival when compared with gemcitabine administered as a standard 30-minute infusion. Comparisons between these novel regimens have been limited. We therefore performed a randomized phase II study of four investigational chemotherapy regimens in pts with documented metastatic pancreatic cancer. METHODS: Pts were randomized to receive one of the following four treatments: gem 1000 mg/m2 d 1, 8, 15 with cisplatin 50 mg/m2 d1, 15 q 28d (Arm A); gem 1500 mg/m2 at a fixed dose rate of 10 mg/m2/minute d1, 8, 15 q 28d (Arm B); gem 1000 mg/m2 d1, 8 with docetaxel 40 mg/m2 d1, 8 q 21d (Arm C); or gem 1000 mg/m2 d1, 8 with irinotecan 100 mg/m2 d1, 8 q 21d (Arm D). Planned follow up per pt is 6 months. RESULTS: Two hundred and fifty-one pts (61-65 per arm) were enrolled, with the following characteristics: median age 60.7 (range (31-84); M/F = 157/94; ECOG PS 0/1/2 = 49/86/18. Median follow-up time is 4.8 months. Pts were followed for overall survival, tumor response, time to tumor progression, and toxicity. The major toxicities experienced by 198 enrolled pts for whom data is currently available are shown in Table 1. Three pts experienced treatment related deaths: 1 (2%) in Arm A and 2 (4%) in Arm B. CONCLUSIONS: While the specific toxicities differ to some degree between regimens, all four regimens have acceptable toxicity profiles. Accrual to the trial has been completed. Updated toxicity data, as well as preliminary data for survival, response, and time to tumor progression will be presented at the annual meeting. [Figure: see text] [Table: see text].
Kulke, MH; Niedzwiecki, D; Tempero, MA; Hollis, DR; Mayer, RJ
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