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A phase II study of combined CPT-11 and mitomycin-C in platinum refractory clear cell and mucinous ovarian carcinoma.

This article reviews the preliminary but encouraging clinical data obtained from patients with platinum-refractory clear cell or mucinous carcinoma of the ovary who were treated with a chemotherapy regimen including irinotecan hydrochloride (CPT-11). Twenty-five patients with platinum-refractory macroscopic disease of which histologic type was either clear cell or mucinous carcinoma were treated. CPT-11 was administered at a dose of 120 mg/m2 intravenously (i.v.) over 4 hours on days 1 and 15, and mitomycin-C (MMC) was given IV as a bolus at a dose of 7 mg/m2 on days 1 and 15. At least 2 cycles of this regimen, 4 weeks apart, were given to the 25 patients. After a median of 4 cycles (range 2 to 8), we observed objective responses in 13 patients (52%), with 5 complete responses (CRs; 20%) and 8 (32%) partial responses (PRs) (95% confidence interval, 32.4% to 71.6%, 4.3% to 35.7%, 13.7% to 50.3%, respectively). The median overall survival time for all 25 patients was 15.3 months (range 3.5 to 38.0). Median overall survival time of the responders was 33.7 months versus 6.1 months of the non-responders (Log-rank, P = 0.0003). The median progression-free survival times for patients obtaining CR, PR, and CR+PR were 31.8 months (range 12.9 to 34.4), 10.5 months (range 5.6 to 18.2), and 12.9 months (range 5.6 to 34.4), respectively. Toxic effects were acceptable and included manageable haematologic reactions, diarrhoea, nausea/vomiting, and alopecia.