title: Phase I trial of oxaliplatin plus S-1 chemotherapy in patients with metastatic colorectal cancer.
abstract: Advanced colorectal cancer can be effectively treated with S-1, as well as with a combination of oxaliplatin, 5-fluorouracil (5FU) and leucovorin (LV). However, S-1 together with oxaliplatin may provide a more convenient alternative to 5FU/LV. To evaluate the performance of S-1 combined with oxaliplatin for patients with colorectal cancer, we conducted a Phase I clinical trial in an outpatient setting. We administered S-1 to 15 patients with advanced colorectal adenocarcinoma for two weeks followed by one week of rest. Oxaliplatin was also administered on day 1 of the S-1 cycle. The dose of oxaliplatin was increased from 40 to 85 mg/m(2) to define the maximum tolerated dose and recommended dose in preparation for a Phase II trial. We administered 102 courses of treatment to 15 patients. Grade 3 thrombocytopenia developed in only 1 patient at a dose of 85 mg/m(2) of oxaliplatin plus oral S-1. No other grade 3-4 toxicities developed. No dose-limiting toxicity developed at level 4 of our regimen (oxaliplatin 85 mg/m(2)), and the recommended dose for a Phase II trial was 85 mg/m(2) of oxaliplatin in an outpatient setting.
authors.affiliation: Department of Surgical Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, Hiroshima 734-8553, Japan.
authors.forename: Manabu
authors.initials: M
authors.lastname: Emi
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Yamaguchi
authors.forename: Jun
authors.initials: J
authors.lastname: Hihara
authors.forename: Katsuji
authors.initials: K
authors.lastname: Hironaka
authors.forename: Morihito
authors.initials: M
authors.lastname: Okada