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Phase II trial of 96-hour paclitaxel plus oral estramustine phosphate in metastatic hormone-refractory prostate cancer.
- Source :
-
Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 1997 Sep; Vol. 15 (9), pp. 3156-63. - Publication Year :
- 1997
-
Abstract
- 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).<br />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.<br />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.<br />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.
- Subjects :
- Administration, Oral
Adult
Aged
Aged, 80 and over
Antineoplastic Agents, Alkylating administration & dosage
Antineoplastic Agents, Hormonal administration & dosage
Antineoplastic Agents, Phytogenic administration & dosage
Antineoplastic Combined Chemotherapy Protocols administration & dosage
Antineoplastic Combined Chemotherapy Protocols adverse effects
Disease-Free Survival
Drug Administration Schedule
Estramustine administration & dosage
Humans
Infusions, Intravenous
Male
Middle Aged
Paclitaxel administration & dosage
Survival Analysis
Treatment Outcome
Adenocarcinoma drug therapy
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Prostatic Neoplasms drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 0732-183X
- Volume :
- 15
- Issue :
- 9
- Database :
- MEDLINE
- Journal :
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 9294479
- Full Text :
- https://doi.org/10.1200/JCO.1997.15.9.3156