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Japanese Journal of Clinical Oncology Advance Access originally published online on November 22, 2005
Japanese Journal of Clinical Oncology 2005 35(12):733-738; doi:10.1093/jjco/hyi190
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© 2005 Foundation for Promotion of Cancer Research

Phase I Study of Fixed Dose Rate Infusion of Gemcitabine in Patients with Unresectable Pancreatic Cancer

Junji Furuse1, Hiroshi Ishii1, Takuji Okusaka2, Michitaka Nagase1, Kohei Nakachi1, Hideki Ueno2, Masafumi Ikeda2, Chigusa Morizane2 and Masahiro Yoshino1

1 Division of Hepatobiliary and Pancreatic Medical Oncology, National Cancer Center Hospital East, Kashiwa, Chiba and 2 Division of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan

For reprints and all correspondence: Junji Furuse, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan. E-mail: jfuruse{at}east.ncc.go.jp

Received July 20, 2005; accepted September 24, 2005

Objective: The purpose of this study was to determine the feasible dose of gemcitabine when administered as a fixed dose rate infusion (10 mg/m2/min) on a weekly schedule to Japanese patients with unresectable advanced pancreatic cancer.

Methods: Patients were required to have histologically or cytologically proven locally advanced or metastatic pancreatic cancer for which they had received no previous chemotherapy. Gemcitabine was administered intravenously weekly for three consecutive weeks every 4 weeks. Patients at three dose levels were scheduled to receive escalating doses of gemcitabine: 1000 mg/m2 over 100 min (Level 1), 1200 mg/m2 over 120 min (Level 2) and 1500 mg/m2 over 150 min (Level 3).

Results: A total of 16 patients were enrolled in this study between December 2003 and September 2004. Maximum-tolerated dose was not reached during the first course. Dose-limiting toxicity was Grade 4 neutropenia. Grade 3 or 4 neutropenia was observed at Level 3 in all six patients in the first course, and administration of gemcitabine on Day 8 or 15 was skipped in all six patients. Non-hematologic toxicity was mild and the most common symptoms were anorexia, nausea and vomiting. Partial response was achieved in 1 of the 17 patients (7%). Median overall survival was 7.3 months.

Conclusions: Gemcitabine administered at a rate of 10 mg/m2/min was tolerated up to 1500 mg/m2, but 1200 mg/m2 represented a more appropriate recommended dose in further studies owing to neutropenia in Japanese patients with advanced pancreatic cancer.

Key Words: advanced pancreatic cancer • systemic chemotherapy • gemcitabine • fixed dose rate infusion


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