A phase II study of irinotecan in combination with doxifluridine, an intermediate form of capecitabine, in patients with metastatic colorectal cancer.
|
| Abstract |
The purpose of this study was to examine the efficacy of a combination treatment of sequential irinotecan and doxifluridine, an intermediate of capecitabine, evaluated by the response rate and safety in patients with metastatic colorectal cancer. In all, 60 metastatic colorectal cancer patients with measurable disease were enrolled. The schedule of the treatment consisted of a 90 min intravenous (IV) infusion of irinotecan 150 mg/m2 for on days 1 and 15, and 600-1,000 mg/body of oral doxifluridine on days 3-14 and 17-28. Cycles were repeated every 35 days. A median of three cycles of the combination therapy (range 1-14 cycles) was administered. A total of 57 patients (95%) completed at least two cycles of the therapy without any dose reductions. There was one complete response and 23 partial responses with an overall response rate of 40% [95% confidence interval (CI): 28-53%]. A total of 19 patients had stable disease, 43(72%) achieved disease control. The median time to progression was 5.9 months and the median overall survival was 20.5 months. Ten (17%) and 17 (28%) patients developed Grade 3-4 leukopenia and neutropenia, respectively. Grade 3-4 fatigue was observed in 7(12%) patients, nausea in five (8%), vomiting in four (7%), and diarrhea,in three (5%) patients. No treatment-related deaths were noted during the study. From these results, the combination of sequential irinotecan and doxifluridine is considered to be an effective, easy-to-administer regimen with acceptable tolerability.
|
|---|---|
| Authors | Takeshi Kato, Hideyuki Mishima, Masakazu Ikenaga, Kouhei Murata, Hideyuki Ishida, Mutsumi Fukunaga, Hirofumi Ota, Shusei Tominaga, Tadashi Ohnishi, Masahiro Amano, Kimimasa Ikeda, Masataka Ikeda, Mitsugu Sekimoto, Junichi Sakamoto, Morito Monden |
| Journal | Cancer chemotherapy and pharmacology (Cancer Chemother Pharmacol) Vol. 61 Issue 2 Pg. 275-81 (Feb 2008) ISSN: 0344-5704 [Print] Germany |
| PMID | 17429630 (Publication Type: Clinical Trial, Phase II, Journal Article, Meta-Analysis, Research Support, Non-U.S. Gov't) |
| Chemical References |
|
| Topics |
|
Join CureHunter, for free Research Interface BASIC access!
Realize the full power of the drug-disease research graph!