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| |  ASCO: Gemcitabine and Paclitaxel Followed by Carboplatin Demonstrates Efficacy in Urothelial Cancers By Peggy Peck ORLANDO, FL -- May 21, 2002 -- Results of a phase I/II trial of a novel schedule of gemcitabine and paclitaxel followed by carboplatin in patients with urothelial cancers and other advanced malignancies suggest this sequence is active and has minimal toxicity. Robert DiPaola, MD, and colleagues from the Cancer Institute of New Jersey, New Brunswick, New Jersey reported the results on May 20 at the 38th Annual Meeting of the American Society of Clinical Oncology (ASCO). Dr. DiPaola said preclinical studies demonstrated that paclitaxel administered prior to carboplatin demonstrated greater cytotoxicity in T24 bladder and DU145 prostate cancer cells than did the reverse order. "The same increased activity was demonstrated in this small study," he said. The study enrolled 37 patients with transitional cell cancer and other advanced malignancies. The effect of the drug sequence on tumor cell viability was assessed with a tetrazolium assay on T24 bladder and DU145 prostate cancer cells. Patients were treated with gemcitabine and paclitaxel on days 1, 8, and 15 for each 28-day cycle. Carboplatin was administered on day 2 at an area under the curve (AUC) of 5. The recommended phase II dose was defined as 70 mg/mē paclitaxel, 300 mg/mē gemcitabine, and carboplatin with AUC of 5. Dr. DiPaola said therapy was well tolerated, with fever and neutropenia occurring in only one patient at the recommended phase II dosing. There was no grade 4 thrombocytopenia occurred in the trial, but grade 3 thrombocytopenia occurred in five of 21 patients treated at the recommended phase II dosing. Nine patients achieved a partial tumor response and two patients achieved a complete response. Out of the 15 patients with transitional cell cancer who had at least two cycles of therapy, six had a partial response and two had a complete response. Based on the results, Dr. DiPaola concluded that a phase III trial that compares this schedule to other schedules of these three drugs is warranted.
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