PHASE-II STUDY OF PROLONGED INFUSION OF TAXOL IN PATIENTS WITH METASTATIC COLORECTAL-CARCINOMA

Purpose: Taxol represents a new class of anticancer agents with activi ty 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 patien ts with metastatic measurable colorectal carcinoma who had had one pri or 5-FU-based chemotherapy. Methods: Patients with measurable metastat ic colorectal carcinoma were eligible. Patients had to have normal liv er, renal, and bone marrow functions. Written informed consent was obt ained from ail patients. The starting dose of Taxol was 150 mg/m(2) in fused over 120-hours in the outpatient setting. Taxol was repeated eve ry 21 days. Results: Fifteen patients were registered. Among 14 evalua ble patients, we did not observe any complete or partial response. Maj or toxicity included myelosuppression and mucositis. There was no trea tment-related death. Conclusion: Taxol administered by this schedule w as found ineffective in patients with metastatic colorectal carcinoma who had previously received one 5-FU-based chemotherapy.