A phase I/II dose escalation study of carboplatin in the treatment of newly diagnosed patients with advanced ovarian cancer receiving paclitaxel

The objective of this study was to determine the maximum tolerated dose of carboplatin when administered with paclitaxel in previously untreated patie nts with ovarian cancer. Patients were treated with paclitaxel at 225 mg/m( 2) for 3 hours followed by carboplatin at an area under the curve (AUC) of 6, 7, 8, or 9 every 3 weeks. Granulocyte colony-stimulating factor was adde d if needed to maintain dose intensity before dose reductions were used for grade 4 hematologic toxicity or febrile neutropenia. Twenty-two patients w ere enrolled in the study. At the AUC 6 level, five of six patients finishe d all six cycles. At the AUC 7 level, four of five patients completed six c ycles, although three required dose reductions for toxicity. At the AUC 8 l evel, all four patients completed six cycles and two required dose reductio ns. The AUC 9 level was not well tolerated. Only four of seven patients com pleted six cycles. Neutropenia was common, and transient thrombocytopenia w as more severe and required dose reduction, especially in later cycles. An AUC of 8 is the maximum tolerated dose of carboplatin in combination with p aclitaxel at 225 mg/m2 for 3 hours.