Biweekly paclitaxel (Taxol) and cisplatin in breast and ovarian cancer

Two trials are being conducted to evaluate paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) combined with cisplatin in previously treated and untreated breast and ovarian cancer. Preliminary results are presented. The objectives of these nonrandomized trials are (1) to determine the toxicity of paclitaxel/cisplatin in a biweekly schedule, (2) to establish the maximum tolerated dose of paclitaxel in combination with a fixed dose of cisplatin (60 mg/m2), (3) to determine the feasibility of repeated biweekly administrations, and (4) to evaluate the efficacy of the combination in these diseases. In the breast cancer study, 22 patients have been enrolled to date and eight patients have completed treatment. Dose-limiting neutropenia, which occurred with the starting dose of paclitaxel (90 mg/m2) followed by 60 mg/m2 cisplatin, has precluded any attempts to escalate the paclitaxel dose. Overall, the regimen has been well tolerated at the doses just described. There has been little grade III and no grade IV nonhematologic toxicity. Among 16 patients currently evaluable for response, four had a complete response and II had a partial response, for an overall response rate of 94%. In the ovarian cancer study, 14 patients have been enrolled thus far. Paclitaxel/cisplatin appears to be well tolerated, although it is still too early to assess response rates or to define the MTD. Patients continue to be accrued in both trials.