Journal of Clinical Oncology, Vol 12, 2301-2308, Copyright © 1994 by American Society of Clinical Oncology
Phase II trial of docetaxel in patients with platinum-refractory advanced ovarian cancer
P Francis, J Schneider, L Hann, C Balmaceda, R Barakat, M Phillips and T Hakes
Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY.
PURPOSE: This phase II study was conducted to evaluate the efficacy and
toxicity of docetaxel in the treatment of patients with platinum-
refractory ovarian cancer. PATIENTS AND METHODS: Twenty-five patients with
platinum-refractory advanced ovarian cancer were treated. Twenty of the
patients had failed to respond to platinum-based front-line chemotherapy
and five had failed to respond to platinum-based therapy repeated at
relapse. One patient had received prior pelvic radiation therapy. Patients
were required to have bidimensionally measurable disease. Docetaxel was
administered at a dose of 100 mg/m2 intravenously (i.v.) over 1 hour every
21 days. Twenty patients received no corticosteroid premedication and five
received premedication with corticosteroids and antihistamines. RESULTS:
Eight of 23 assessable patients (35%) had a partial response (PR; 95%
confidence interval, 16% to 57%). The median response duration was 5
months. Hospitalization for toxicity, predominantly neutropenic fever,
occurred in 12 patients (48%) and 16% of courses. Anemia was common in the
study population. Nonhematologic toxicities included alopecia, rash, fluid
retention, diarrhea, peripheral neuropathy, and hypersensitivity reactions.
CONCLUSION: Docetaxel demonstrates significant activity in patients with
platinum-refractory advanced ovarian cancer. Routine premedication is
recommended. Further investigations of this agent in ovarian cancer,
including combinations with other active agents, appear indicated.
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