A pilot study evaluating a novel regimen comprised of carboplatin, paclitaxel, and bevacizumab for advanced-stage ovarian carcinoma.

OBJECTIVES: The purpose of this study was to assess the toxicity, progression-free survival, and response rate of advanced stage ovarian carcinoma patients treated with a novel regimen comprising paclitaxel, carboplatin, and bevacizumab.

METHODS: All eligible patients were treated with intravenous paclitaxel (80 mg/m2) on days 1, 8, and 15; carboplatin (area under the curve, 5) on day 1; and bevacizumab (10 mg/kg) on days 1 and 15; Q28 days for 6 cycles. Bevacizumab was administered during cycles 2 through 6.

RESULTS: Twenty patients received a combined total of 102 cycles of primary induction chemotherapy (median, 6; range, 2-6) and were evaluable for toxicity assessment. Six (5.9%) cycles were associated with grades 3 and 4 neutropenia, which resulted in the removal of 2 patients. Only 1 (0.98%) cycle was associated with grade 3 thrombocytopenia. Moreover, one patient developed a colorectal fistula and was subsequently removed from the study. Grade 3 hypertension was encountered and successfully managed in 3 participants. In the group of 13 patients who were evaluated for response, the overall response rate was 61.6% (30.8% complete response). Four patients exhibited stable disease, and 1 patient had progressive disease. The patient group's mean progression-free survival was 5.8 months.

CONCLUSIONS: The tolerable hematologic toxicity and reasonable response rate after paclitaxel, carboplatin, and bevacizumab suggest that this regimen has moderate activity and can be safely administered to an advanced-stage ovarian carcinoma population. We were further encouraged by the reasonable incidence of hypertension. However, because 4 patients were removed from the study because of either grade ≥ 2 neutropenia or thrombocytopenia, we suggest that colony-stimulating factors and cautious patient observation should be considered with this regimen.