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

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

Research output: Contribution to journalArticle

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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 ≥ 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.

Original languageEnglish (US)
Pages (from-to)110-116
Number of pages7
JournalClinical Genitourinary Cancer
Volume6
Issue number2
DOIs
StatePublished - Jan 1 2008

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docetaxel
Estramustine
Prostatic Neoplasms
Leukemia
Hormones
Warfarin
Neoplasms
Prostate-Specific Antigen
Embolism and Thrombosis
Antineoplastic Agents
Dexamethasone
Disease-Free Survival
Fatigue
Neutrophils
sulindac sulfone
Safety
Drug Therapy
Survival

Keywords

  • Deep vein thrombosis
  • Progressionfree survival
  • Prostate-specific antigen
  • Selective apoptotic antineoplastic drug

ASJC Scopus subject areas

  • Oncology
  • Urology

Cite this

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

In: Clinical Genitourinary Cancer, Vol. 6, No. 2, 01.01.2008, p. 110-116.

Research output: Contribution to journalArticle

Dawson, NA, Halabi, S, Ou, SS, Biggs, DD, Kessinger, A, Vogelzang, N, Clamon, GH, Nanus, DM, Kelly, WK & Small, EJ 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, vol. 6, no. 2, pp. 110-116. https://doi.org/10.3816/CGC.2008.n.017
Dawson, Nancy A. ; Halabi, Susan ; Ou, San San ; Biggs, David D. ; Kessinger, Anne ; Vogelzang, Nicholas ; Clamon, Gerald H. ; Nanus, David M. ; Kelly, W. Kevin ; Small, Eric J. / 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. In: Clinical Genitourinary Cancer. 2008 ; Vol. 6, No. 2. pp. 110-116.
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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 ≥ 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.",
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