Phase II study of prolonged infusion of Taxol in patients with metastatic colorectal carcinoma.

Abstract

Taxol represents a new class of anticancer agents with activity against a wide variety of solid tumors. In preclinical systems, its cytotoxicity is schedule dependent with prolonged exposure being more effective. We studied a 120-hour infusion schedule of Taxol in patients with metastatic measurable colorectal carcinoma who had had one prior 5-FU-based chemotherapy. Patients with measurable metastatic colorectal carcinoma were eligible. Patients had to have normal liver, renal, and bone marrow functions. Written informed consent was obtained from all patients. The starting dose of Taxol was 150 mg/m2 infused over 120-hours in the outpatient setting. Taxol was repeated every 21 days. Fifteen patients were registered. Among 14 evaluable patients, we did not observe any complete or partial response. Major toxicity included myelosuppression and mucositis. There was no treatment-related death. Taxol administered by this schedule was found ineffective in patients with metastatic colorectal carcinoma who had previously received one 5-FU-based chemotherapy.