A phase II study of estramustine, docetaxel, and exisulind in patients with hormone- refractory prostate cancer: results of cancer and leukemia group B trial 90004.

Authors

• Nancy A Dawson
• Susan Halabi
• San-San Ou
• David D Biggs
• Anne Kessinger
• Nicholas Vogelzang
• Gerald H Clamon
• David M Nanus
• W Kevin Kelly
• Eric J Small

Publication/Presentation Date

9-1-2008

Abstract

PURPOSE: Docetaxel/estramustine is a known active regimen in hormonerefractory prostate cancer (HRPC). A phase II study was conducted to assess the safety and efficacy of docetaxel/estramustine combined with exisulind, an apoptotic antineoplastic drug.

PATIENTS AND METHODS: Eighty men with chemotherapy-naive HRPC were enrolled in a multicenter, cooperative group study. The treatment regimen consisted of oral estramustine (280 mg 3 times daily for 5 days), docetaxel 70 mg/m2, oral exisulind (250 mg twice daily), oral dexamethasone (8 mg twice daily for 3 days), and oral warfarin (2 mg daily).

RESULTS: Seventy-five eligible patients were treated with a median of 6 cycles of therapy. Fortyseven patients (62.7%; 95% CI, 50.7%-73.6%) had a > or = 50% decline in prostate-specific antigen levels. Forty-six patients had measurable disease with 6 partial responses (13%; 95% CI, 4.9%-26.3%). The main grade 3/4 toxicities were neutrophils (79%), fatigue (15%), and thrombosis/embolism (10%). The median time to first progression was 5.1 months (95% CI, 4.4-6.3 months) and the median survival time was 17.8 months (95% CI, 14.7-20.1 months).

CONCLUSION: The combination of estramustine/docetaxel/exisulind was associated with significant thomboembolic toxicity despite prophylactic warfarin. The contribution of exisulind to toxicity is uncertain. Prostate-specific antigen decline, response rates, and progression-free and overall survival are similar to those reported with docetaxel/estramustine.

Volume

6

Issue

2

First Page

110

Last Page

116

ISSN

1558-7673

Published In/Presented At

Dawson, N. A., Halabi, S., Ou, S. S., Biggs, D. D., Kessinger, A., Vogelzang, N., Clamon, G. H., Nanus, D. M., Kelly, W. K., Small, E. J., & Cancer And Leukemia Group B (2008). A phase II study of estramustine, docetaxel, and exisulind in patients with hormone- refractory prostate cancer: results of cancer and leukemia group B trial 90004. Clinical genitourinary cancer, 6(2), 110–116. https://doi.org/10.3816/CGC.2008.n.017

Disciplines

Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods

PubMedID

18824434

Department(s)

Administration and Leadership

Document Type

Article