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Japanese Journal of Clinical Oncology Advance Access published online on July 15, 2008
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyn062
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© The Author (2008). Published by Oxford University Press. All rights reserved

A Phase I Study of Bolus 5-fluorouracil and Leucovorin Combined with Weekly Paclitaxel (FLTAX) as First-line Therapy for Advanced Gastric Cancer

Junichi Matsubara, Yasuhiro Shimada, Atsuo Takashima, Daisuke Takahari, Yoshinori Hirashima, Natsuko T. Okita, Takako E. Nakajima, Ken Kato, Tetsuya Hamaguchi, Yasuhide Yamada and Kuniaki Shirao

Gastrointestinal Oncology Division, National Cancer Center Hospital, Tokyo, Japan

For reprints and all correspondence: Junichi Matsubara, 5-1-1 Tsukiji, Chuo-ku, Tokyo 1040045, Japan. E-mail: junjun0808{at}hotmail.com

Received May 10, 2008; accepted June 20, 2008

Objective: To determine the dose-limiting toxicity (DLT) and the maximum-tolerated dose (MTD) of combination chemotherapy with leucovorin-modulated weekly bolus 5-fluorouracil (5-FU) and weekly paclitaxel in patients with advanced gastric cancer (GC).

Methods: Chemotherapy-naïve patients with histologically proven metastatic or recurrent GC were enrolled. Paclitaxel was administered as a 1-h intravenous (i.v.) infusion followed by 5-FU as a bolus i.v. infusion on Days 1, 8 and 15. A 2-h i.v. infusion of l-leucovorin was started at the same time as the paclitaxel infusion on Days 1, 8 and 15. Treatment cycles were repeated every 28 days until disease progression or unacceptable toxicity occurred. Patients were scheduled to receive 5-FU, l-leucovorin and paclitaxel at four dose levels (mg/m2/week): 500/250/60 (level 1), 500/250/80 (level 2), 600/250/80 (level 3) and 600/250/100 (level 4), respectively.

Results: Eighteen patients were enrolled. During the first cycle of the highest dose level (level 4), two of the six patients had DLT involving Grade 3 diarrhea and Grade 3 skin rash. Furthermore, three of the four patients who received the second consecutive cycle of treatment at dose level 4 had Grade 4 neutropenia. Dose level 3 was thus determined to be the MTD. Eleven (61%) of the 18 patients had partial responses, and the median progression-free survival time was 6.8 months.

Conclusions: The MTD and the recommended dose for phase II studies of this regimen were determined to be 5-FU 600 mg/m2/week, l-leucovorin 250 mg/m2/week and paclitaxel 80 mg/m2/week.

Key Words: gastric cancer • chemotherapy • weekly paclitaxel • bolus 5-fluorouracil • leucovorin


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