PHASE I II STUDY OF PIXY321 IN COMBINATION WITH CYCLOPHOSPHAMIDE AND CARBOPLATIN IN THE TREATMENT OF OVARIAN-CANCER/

OBJECTIVE: Our purpose was to evaluate the safety and biologic effects of PIXY321 after chemotherapy in patients with ovarian carcinoma. STU DY DESIGN: A multicenter, nonrandomized, phase I/II study of subcutane ously administered PIXY321 after the second cycle of chemotherapy in c ohorts of three or more patients at 50, 125, 250, 500, 750, or 1000 mu g/m(2) per day. RESULTS: Cyclophosphamide (600 mg/m(2)) and carboplat in (400 mg/m(2)) were administered every 28 days to 34 patients. At do ses greater than or equal to 500 mg/m(2) per day, the median nadir pla telet and median nadir absolute neutrophil counts in cycle 2 (with PIX Y321) compared with cycle 1 (control) were both higher in 13 of 26 (50 %) patients. Twenty-one patients were withdrawn from the study. A tota l of 17 of 21 (81%) were removed for myelosuppression (n = 15) or PIXY 321 toxicity (n = 2). A total of 28 of 34 (82%) patients had injection site reactions. Thirty-seven nonhematologic grade 3 events occurred. CONCLUSIONS: At these doses and schedules PIXY321 can be safely admini stered. Aggressive dosing of cyclophosphamide and carboplatin could no t be maintained for six cycles in the majority (62%) of patients.