Journal of Clinical Oncology, Vol 15, 3156-3163, Copyright © 1997 by American Society of Clinical Oncology
Phase II trial of 96-hour paclitaxel plus oral estramustine phosphate in metastatic hormone-refractory prostate cancer
GR Hudes, F Nathan, C Khater, N Haas, M Cornfield, B Giantonio, R Greenberg, L Gomella, S Litwin, E Ross, S Roethke and C McAleer
Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA. g_hudes@fccc.edu
PURPOSE: To evaluate the antitumor activity of 96-hour paclitaxel and daily
oral estramustine phosphate (EMP) in patients with metastatic
hormone-refractory prostate cancer (HRPC). PATIENTS AND METHODS: Thirty-
four patients with adenocarcinoma of the prostate that progressed after one
or more hormonal therapies and a trial of antiandrogen withdrawal were
enrolled onto this phase II trial. Patients received paclitaxel 120 mg/m2
by 96-hour intravenous (i.v.) infusion on days 1 through 4 of each 21-day
cycle, together with daily oral EMP 600 mg/m2/d, continuously. RESULTS:
Four of nine patients with measurable disease had objective responses (one
complete response [CR] and three partial responses [PRs]) in liver (two
patients) or nodes (two patients) of 2, 6, 8, and 20 months' duration. Of
25 assessable patients with metastases limited to bone, 14 had a > or =
50% decline in pretreatment prostate-specific antigen (PSA) level sustained
for at least 6 weeks and seven had a > or = 80% decline. Overall, 17 of
32 patients (53.1%) with elevated pretreatment PSA levels had a > or =
50% decline of PSA and nine (28.1%) had a > or = 80% decrease. The main
toxicities (> or = grade 2) were nausea, fluid retention, and fatigue,
which occurred in 33%, 33%, and 24.2% of patients. Median time to
progression, based on increasing PSA level and other clinical criteria, was
22.5 weeks. The estimated median overall survival time is 69 weeks.
CONCLUSION: The combination of EMP and 96-hour paclitaxel is an active
regimen for patients with HRPC. These results further support the
therapeutic strategy of combining agents that impair microtubule function
by complementary mechanisms.
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