Phase I study of topotecan and radiation therapy in advanced cervical cancer

Objective. The goal of this study was to determine the maximal tolerated dose (MTD) of topotecan given with external-beam radiotherapy in advanced cervical cancer. Methods. A prospective Phase I trial of topotecan given with standard external-beam radiotherapy was performed in patients with advanced squamous cell carcinoma of the cervix. Patients were treated with a starting dose of 0.5 mg/m(2) and escalated by 0.25 mg/m(2). Nine patients were treated. Hematologic and nonhematologic toxicity were measured. Results. Patients were treated with 1.0 mg/m(2) daily for 5 days on Days 1-5 and 22-26 concomitantly with radiotherapy without significant toxicity. Grade III anemia in one case and Grade II leukopenia in two cases were seen in the three patients at this dose level. Dose-limiting toxicity was not reached. Conclusion. Topotecan can be safely administered at a dose of 1.0 mg/m(2) during external-beam radiotherapy for advanced cervical cancer. (C) 2002 Elsevier Science (USA).