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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.

Publication ,  Journal Article
Dawson, NA; Halabi, S; Ou, S-S; Biggs, DD; Kessinger, A; Vogelzang, N; Clamon, GH; Nanus, DM; Kelly, WK; Small, EJ; Cancer And Leukemia Group B,
Published in: Clin Genitourin Cancer
September 2008

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.

Duke Scholars

Published In

Clin Genitourin Cancer

DOI

ISSN

1558-7673

Publication Date

September 2008

Volume

6

Issue

2

Start / End Page

110 / 116

Location

United States

Related Subject Headings

  • Thromboembolism
  • Taxoids
  • Survival Analysis
  • Sulindac
  • Prostatic Neoplasms
  • Prostate-Specific Antigen
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Humans
 

Citation

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MLA
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Dawson, N. A., Halabi, S., Ou, S.-S., Biggs, D. D., Kessinger, A., Vogelzang, N., … 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. Clin Genitourin Cancer, 6(2), 110–116. https://doi.org/10.3816/CGC.2008.n.017
Dawson, Nancy A., Susan Halabi, San-San Ou, David D. Biggs, Anne Kessinger, Nicholas Vogelzang, Gerald H. Clamon, et al. “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.Clin Genitourin Cancer 6, no. 2 (September 2008): 110–16. https://doi.org/10.3816/CGC.2008.n.017.
Dawson NA, Halabi S, Ou S-S, Biggs DD, Kessinger A, Vogelzang N, et al. 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. Clin Genitourin Cancer. 2008 Sep;6(2):110–6.
Dawson, Nancy A., et al. “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.Clin Genitourin Cancer, vol. 6, no. 2, Sept. 2008, pp. 110–16. Pubmed, doi:10.3816/CGC.2008.n.017.
Dawson NA, Halabi S, Ou S-S, Biggs DD, Kessinger A, Vogelzang N, Clamon GH, Nanus DM, Kelly WK, Small EJ, Cancer And Leukemia Group B. 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. Clin Genitourin Cancer. 2008 Sep;6(2):110–116.
Journal cover image

Published In

Clin Genitourin Cancer

DOI

ISSN

1558-7673

Publication Date

September 2008

Volume

6

Issue

2

Start / End Page

110 / 116

Location

United States

Related Subject Headings

  • Thromboembolism
  • Taxoids
  • Survival Analysis
  • Sulindac
  • Prostatic Neoplasms
  • Prostate-Specific Antigen
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Humans