Treatment of recurrent platinum resistant ovarian or peritoneal cancer with gemcitabine and doxorubicin: A phase I/II trial of the Puget Sound Oncology Consortium (PSOC 1602)

OBJECTIVE: This study was undertaken to determine the degree of toxicity, response rate, and evaluate quality of life (QOL) in women receiving gemcitabine in combination with doxorubicin for platinum-resistant and refractory ovarian or peritoneal cancer. STUDY DESIGN: This was a phase I/II prospective trial. MATERIALS AND METHODS: Nine patients were enrolled in the phase I portion. Initial doses of gemcitabine; 800 mg/m(2) intravenously on days 1, 8, and 15, and doxorubicin, 25 mg/m(2) intravenously on days 1, 8, and 15 in a 28-day cycle resulted in dose limiting toxicity secondary to thrombocytopenia and neutropenia. Forty patients were treated on the phase 11 portion with gemcitabine, 700 mg/m(2) intravenously on days 1 and 8, and doxorubicin 20 mg/m(2) intravenously on days 1 and 8 with granulocyte colony-stimulating factor administered on days 2 to 7 and 9 to 14 in a 21-day cycle. QOL was assessed with Fact-O. RESULTS: The median number of previous chemotherapy regimens for the 49 women was 2 (range 1-5). There were 2 complete and 9 partial responses, for an overall response rate of 24%. Median duration of response was 5 months. Fourteen women (31%) had stable disease with median duration of response of 5 months. Median survival for the entire group was 12 months. Toxicity was primarily hematologic, and only 3 patients discontinued therapy because of toxicity. QOL surveys indicated that this was a well-tolerated regimen. CONCLUSION: The combination of gemcitabine and doxorubicin can be safely administered, Overall, approximately 55% of women with platinum-resistant ovarian or peritoneal cancer benefit from this regimen with response or stabilization of disease.