Objective. To evaluate the efficacy and toxicity of Oxaliplatin and 5 -Fluorou racil (5-FU)/Leucovorin (LV) combination in ovarian cancer relapsing within 2 y ears of prior platinum-based chemotherapy in a phase II trial. Methods. Eligibl e patients had at least one prior platinum-based chemotherapy regimen, elevated CA-125 ≥60 IU/l, radiological evidence of disease progression and adequate he patic, renal and bone marrowfunction. Patients with raised CA-125 levels alone as marker of disease relapse were not eligible. Oxaliplatin (85 mg/m2) was given on day 1, and 5-Fluorouracil (370 mg/m2) and Leucovorin (30 mg) was given on d ays 1 and 8 of a 14-day cycle. Results. Twenty-seven patients were enrolled. T he median age was 57 years (range 42-74 years). The median platinum-free inter val (PFI) was 5 months (range 0-17 months) with only 30%of patients being plat inum sensitive (PFI > 6 months). Six patients (22%) had two prior regimens of c hemotherapy. A total of 191 cycles were administered (median 7; range 2-12). Al l patients were evaluable for toxicity. The following grade 3/4 toxicities were noted: anemia 4%; neutropenia 15%; thrombocytopenia 11%; neurotoxicity 8%; l ethargy 4%; diarrhea 4%; hypokalemia 11%; hypomagnesemia 11%. Among 27 enrol led patients, 20 patients were evaluable for response byWHO criteria and 25 pat ients were evaluable by Rustins CA-125 criteria. The overall response rate (R R) by WHO criteria was 30%(95%CI: 15-52) 展开▼
