We examined appropriate sequence, schedule, and doses of gemcitabine (G) and paclitaxel (T) in patients with persistent or recurrent epithelial ovarian cancer. Patients received a maximum of six cycles of gemcitabine on days 1 and 8 (starting 1000 mg/m2), and paclitaxel (starting 135 mg/m2) on day 8 (groups A and B) or day 1 (group C). Drug sequences (G→T and T→G) were tested in group A. In group A, changing sequences of gemcitabine and paclitaxel infusion were evaluated. Sequence G→T raised grade 3 alanine transaminase in two of three patients leading to use of T→G sequence for remainder of study. In group B, maximum tolerable dose was reached at gemcitabine 1000 mg/m2 and paclitaxel 175 mg/m2. Reducing paclitaxel to 150 mg/m2 allowed escalation of gemcitabine to 1250 mg/m2, but neutropenia-related treatment delays occurred. Giving paclitaxel on day 1 (group C) enabled administration of paclitaxel 175 mg/m2 and gemcitabine 1250 mg/m2 with minimal dose adjustments. The overall response rate was 41.0%, with 2 complete responses and 14 partial responses in 39 eligible patients. The schedule of paclitaxel 175 mg/m2 (day 1) and gemcitabine 1250 mg/m2 (days 1 and 8), with sequence of T→G, appears most suitable with tolerable toxicity and promising activity.
- drug sequence
- phase I
- recurrent ovarian cancer
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This study was sponsored by Eli Lilly and Company.
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