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 II 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.