Phase I and Pharmacologic Study of the Combination of Paclitaxel, Cisplatin, and Topotecan Administered Intravenously Every 21 Days as First-Line Therapy in Patients With Advanced Ovarian Cancer

摘要: PURPOSE: To evaluate the feasibility of administering topotecan in combination with paclitaxel and cisplatin without granulocyte colony-stimulating factor (G-CSF) support as first-line chemotherapy women incompletely resected stage III IV ovarian carcinoma. PATIENTS AND METHODS: Starting doses were 110 mg/m2 administered over 24 hours (day 1), followed by 50 3 2) 0.3 mg/m2/d 30 minutes for 5 consecutive days (days 2 to 6). Treatment was repeated every weeks. After encountering dose-limiting toxicities (DLTs) G-CSF support, maximum-tolerated dose defined μg/kg subcutaneously starting on day 6. RESULTS: Twenty-one patients received a total 116 courses at four different levels. The DLT neutropenia. At first level, all six experienced grade 4 myelosuppression. permitted further escalation topotecan. Nonhematologic toxicities,...