PT - JOURNAL ARTICLE AU - IZUMI TAKEYOSHI AU - FUJIO MAKITA AU - YOSHIFUMI TANAHASHI AU - TADAHIRO YOKOMORI AU - SHIGERU IWAZAKI AU - YOSHIYUKI KAWASHIMA AU - KOTARO IWANAMI AU - TATSUYA YAMADA AU - SUSUMU KAWATE AU - KUNIHIRO HAMADA AU - YUTAKA SUNOSE AU - MIHO YOSHIDA AU - JUN HORIGUCHI AU - HIROSHI IESATO AU - MITSUNOBU KOBAYASHI AU - YASUO MORISHITA TI - A Combination Phase I Study of Weekly Paclitaxel and Doxifluridine in Advanced Gastric Cancer Patients DP - 2005 Mar 01 TA - Anticancer Research PG - 1291--1296 VI - 25 IP - 2B 4099 - http://ar.iiarjournals.org/content/25/2B/1291.short 4100 - http://ar.iiarjournals.org/content/25/2B/1291.full SO - Anticancer Res2005 Mar 01; 25 AB - Background: Preclinical studies have shown that paclitaxel and doxifluridine can act synergistically without overlapping toxicity for the treatment of advanced gastric cancer. The objectives of this study were to determine the maximum tolerated dose (MTD), the dose-limiting toxicity and the recommended Phase II dose for this drug combination. Patients and Methods: Patients with histologically confirmed gastric cancer were eligible for the study. The paclitaxel dose (days 1, 8, 15) was augmented with a fixed dose of doxifluridine (533 mg/m2, 5 days/week) on a 28-day cycle. Results: Eighteen patients were enrolled. The MTD was not reached until the highest dose level. One patient had Grade 3 myelosuppression. The responses of the 13 suitable patients included 1 complete response and 5 partial responses. Conclusion: Although the MTD level could not be definitively established, upon consideration of the lengthy administration time and the effectiveness, the recommended Phase II dose of paclitaxel was concluded to be 80 mg/m2 in combination with doxifluridine at 533 mg/m2. Copyright© 2005 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved