VINBLASTINE, IFOSFAMIDE, GALLIUM NITRATE, AND FILGRASTIM IN PLATINUM-RESISTANT AND PACLITAXEL-RESISTANT OVARIAN-CANCER - A PHASE-II STUDY

The authors performed a phase II trial of the VIG regimen (vinblastine , ifosfamide, and gallium nitrate) in patients who had advanced ovaria n cancer who were refractory to cisplatin and/or carboplatin and whose disease had progressed after paclitaxel-based therapy. This was a hea vily pretreated population, with five patients having received two to three prior chemotherapy regimens and six patients having received mor e than six prior chemotherapy regimens, with an average of 21 therapy cycles per patient. Fourteen patients were treated with vinblastine, 0 .08 mg/kg intravenously on days 1 and 2; ifosfamide, 900 mg/m(2) intra venously on days 1 through 5 with standard mesna uroprotection; and ga llium nitrate administered as a continuous intravenous infusion at 225 mg/m(2) per 24 hours x 120 hours. Granulocyte colony stimulating fact or (G-CSF) was administered subcutaneously at 5 mu g/kg/day beginning on day 7 until day 13. Five of 14 patients achieved a partial response for an overall response rate of 36% (95% confidence interval, 14%-68% ). The median response duration was 14 weeks. Toxicity was primarily h ematologic, with anemia and leukopenia being most significant. There w ere no treatment-related deaths. Further valuation of this regimen in a less heavily pretreated population is warranted.