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Annals of Oncology 12:1729-1735, 2001
© 2001 European Society for Medical Oncology

research-article

Phase I-II study of irinotecan combined with mitomycin-C in patients with advanced gastric cancer*

T. Yamao1,, K. Shirao2, Y. Matsumura2, K. Muro2, Y. Yamada2, M. Goto2, K. Chin1 and Y. Shimada2

1Department of Internal Medicine, Cancer Institute Hospital Tokyo
2Department of Gastrointestinal Oncology, National Cancer Center Hospital Tokyo, Japan

T. Yamao, MD, PhD, Dept. of Internal Medicine, Cancer Institute Hospital, 1-37-1 Kami-ikebukuro, Toshima-ku, Tokyo 170-8455, Japan, E-mail tyamao-gi{at}umin.ac.jp

Background: Irinotecan (CPT-11) shows synergism with mitomycin-C (MMC) in a preclinical setting. The goals of this study were to determine the maximum tolerated dose (MTD), the dose limiting toxicity, the recommended dose (RD), and preliminary anti-tumor activity in a combined CPT-11 and MMC treatment of advanced gastric cancer.

Patients and methods: The study was designed to evaluate escalated doses of CPT-11 and MMC administered every two weeks. Five escalating dose levels were studied (CPT-11/ MMC: 100/5; 125/5; 150/5; 150/7; 150/10 mg/m2).

Results: Thirty-one patients were enrolled. Thirty patients were assessable for toxicity and tumor response for 89 treatment cycles. The median age was 60 years (32–73 years), and most patients (90%) had a performance status of 0 to 1. Fourteen patients were previously treated and 17 were chemotherapy-naive. The MTD was CPT-11 150 mg/m2 plus MMC 10 mg/m2, in which all three patients experienced grade 4 neutropenia, including one episode of prolonged and one of febrile neutropenia, and one patient experienced grade 3 diarrhea during the first cycle. Fifteen partial responses were observed.

Conclusions: The RD based on this phase I-II study was CPT-11 150mg/m2 plus MMC 5 mg/m2 administered every two weeks. This combination demonstrates promising activity against advanced gastric cancer and warrants further investigation in another phase II study.

chemotherapy, clinical trial, gastric cancer, irino-tecan (CPT-11), mitomycin-C, phase I-II study


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