TOPOTECAN IN COLORECTAL-CANCER - A PHASE-II STUDY OF THE EORTC EARLY CLINICAL-TRIALS GROUP

Purpose: This phase II study with the topoisomerase I inhibitor topote can was performed to determine its clinical activity and toxicity in p atients with metastatic or locally unresectable colorectal cancer. Pat ients and methods: Topotecan 1.5 mg/m(2) was administered intravenousl y by 30-minute infusion for 5 days. Fifty-nine patients entered the st udy, 2 were considered ineligible and 57 were evaluable for response a nd toxicity. Results: Partial response was obtained in 4 of 57 evaluab le patients (7%), The median duration of the response was 11 months (r ange 9.3 to 12.2). This topotecan regimen was very well tolerated. A t otal of 290 courses were given, with a median of 4 courses per patient (range, 1 to 18). The major toxic effects were leuko-and neutropenia (91%), grade 3-4 in 48% and 79% of courses, respectively, but with onl y 2 infectious complications. Other side effects were grade 1 alopecia (77%) in 46%, nausea (35%), vomiting (10%), and maculo-papular rash ( 6%). Conclusions: Topotecan administered as a daily-times-five regimen has only minor activity as a single-agent therapy in colorectal cance r.