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Multicenter Phase I Study of Irinotecan plus Raltitrexed in Patients with 5-Fluorouracil-Refractory Advanced Colorectal Cancer
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Multicenter Phase I Study of Irinotecan plus Raltitrexed in Patients with 5-Fluorouracil-Refractory Advanced Colorectal Cancer
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Multicenter Phase I Study of Irinotecan plus Raltitrexed in Patients with 5-Fluorouracil-Refractory Advanced Colorectal Cancer
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Journal Article
Multicenter Phase I Study of Irinotecan plus Raltitrexed in Patients with 5-Fluorouracil-Refractory Advanced Colorectal Cancer
2002
Overview
Irinotecan and raltitrexed are active against advanced colorectal cancer, act through different mechanisms, and have non-overlapping toxicity profiles. In vitro studies have shown a schedule-dependent synergism between both drugs. The aim of this multicenter study was to determine the maximum tolerated dose (MTD) of this combination. Patients with 5-fluorouracil-refractory, advanced colorectal cancer were eligible. Dose escalation consisted of irinotecan (250–350 mg/m 2 as a 60-min infusion) in combination with a fixed dose of raltitrexed (3 mg/m 2 as a 15-min infusion, 1 h after irinotecan). Courses were repeated every 21 days. Three to 6 patients were to be included at each dose level. Dose limiting (NCI-CTC grade 3–4) toxicities (DLT) were assessed during the first 2 cycles. Thirteen patients were recruited (4, 3 and 6 in levels I, II and III, respectively). Main toxicity was diarrhea and asthenia, whereas myelotoxicity was mild. At level III, 2/6 patients experienced DLT (grade 4 diarrhea and neutropenia). The MTD was not reached, but further dose escalation was not attempted. Among 12 patients with measurable disease, 2 partial responses were observed for an overall response rate of 17%. The combination of single-agent full doses of irinotecan (350 mg/m 2 ) and raltitrexed (3 mg/m 2 ) in a 3-weekly schedule is feasible, with mild toxicity and a promising clinical activity. Diarrhea is the DLT, but it is not more common or severe than that described with irinotecan alone.
Publisher
Karger,S. Karger AG
Subject
/ Antimetabolites, Antineoplastic
/ Antineoplastic Combined Chemotherapy Protocols - adverse effects
/ Antineoplastic Combined Chemotherapy Protocols - therapeutic use
/ Biological and medical sciences
/ Camptothecin - administration & dosage
/ Camptothecin - adverse effects
/ Camptothecin - analogs & derivatives
/ Colorectal Neoplasms - drug therapy
/ Colorectal Neoplasms - pathology
/ Female
/ Humans
/ Male
/ Pharmacology. Drug treatments
/ Quinazolines - administration & dosage
/ Quinazolines - adverse effects
/ Thiophenes - administration & dosage
