Skip Navigation


Japanese Journal of Clinical Oncology Advance Access originally published online on July 15, 2008
Japanese Journal of Clinical Oncology 2008 38(8):540-546; doi:10.1093/jjco/hyn062
This Article
Right arrow Full Text Freely available
Right arrow FREE Full Text (PDF) Freely available
Right arrow All Versions of this Article:
38/8/540    most recent
hyn062v1
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrow Request Permissions
Google Scholar
Right arrow Articles by Matsubara, J.
Right arrow Articles by Shirao, K.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Matsubara, J.
Right arrow Articles by Shirao, K.
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?


© 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


Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us    What's this?




Disclaimer: Please note that abstracts for content published before 1996 were created through digital scanning and may therefore not exactly replicate the text of the original print issues. All efforts have been made to ensure accuracy, but the Publisher will not be held responsible for any remaining inaccuracies. If you require any further clarification, please contact our Customer Services Department.