Phase II evaluation of docetaxel plus exisulind in patients with androgen independent prostate carcinoma

Victoria J. Sinibaldi, Kathy Elza-Brown, Jill Schmidt, Mario A. Eisenberger, Eli Rosenbaum, Samuel R. Denmeade, Roberto Pili, Janet Walczak, Sharyn D. Baker, Marianna Zahurak, Michael A. Carducci

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

OBJECTIVES: In this phase II study, the combination of docetaxel and exisulind (a GMP phosphodiesterase inhibitor) was given to patients with metastatic androgen independent prostate cancer (AIPC) to establish efficacy, assess toxicity, and determine pharmacokinetics of docetaxel administered alone and in combination with exisulind. METHODS: Fourteen patients with metastatic AIPC were registered to receive weekly docetaxel for 4 weeks, followed by 2 weeks of rest; repeated up to a maximum of 6 cycles. Exisulind 250 mg was given orally twice a day starting on day 8 of the study and taken continuously. RESULTS: All patients were evaluable for toxicity, response and survival. Grade 3 reversible toxicities included: fatigue, nausea, diarrhea, abdominal pain, rash, syncope, pulmonary edema, deep vein thrombosis, congestive heart failure, and elevations in transaminases, requiring therapy delays and/or dose reductions, or removal from therapy. Only 3 out of 14 patients (21.4%) had a 50% decline in prostate specific antigen (PSA) level that lasted ≥4 weeks; 1 out of 14 patients (7%) had a lymph node response. Median survival was 17.28 months. Docetaxel pharmacokinetics for 11 patients demonstrated mean ± SD clearance values that were similar during week 1 and week 3 when exisulind had been added. CONCLUSIONS: Overall, our trial indicated that the toxicity profile and efficacy of this regimen is unlikely to be substantially better than single agent docetaxel.

Original languageEnglish (US)
Pages (from-to)395-398
Number of pages4
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume29
Issue number4
DOIs
StatePublished - Aug 2006
Externally publishedYes

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docetaxel
Androgens
Prostate
Carcinoma
Prostatic Neoplasms
Pharmacokinetics
Phosphodiesterase Inhibitors
Survival
Syncope
Pulmonary Edema
Prostate-Specific Antigen
Transaminases
Exanthema
Venous Thrombosis
Nausea
Abdominal Pain
Fatigue
sulindac sulfone
Diarrhea
Heart Failure

Keywords

  • Docetaxel
  • Exisulind
  • Prostate cancer

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Sinibaldi, V. J., Elza-Brown, K., Schmidt, J., Eisenberger, M. A., Rosenbaum, E., Denmeade, S. R., ... Carducci, M. A. (2006). Phase II evaluation of docetaxel plus exisulind in patients with androgen independent prostate carcinoma. American Journal of Clinical Oncology: Cancer Clinical Trials, 29(4), 395-398. https://doi.org/10.1097/01.coc.0000225411.95479.b4

Phase II evaluation of docetaxel plus exisulind in patients with androgen independent prostate carcinoma. / Sinibaldi, Victoria J.; Elza-Brown, Kathy; Schmidt, Jill; Eisenberger, Mario A.; Rosenbaum, Eli; Denmeade, Samuel R.; Pili, Roberto; Walczak, Janet; Baker, Sharyn D.; Zahurak, Marianna; Carducci, Michael A.

In: American Journal of Clinical Oncology: Cancer Clinical Trials, Vol. 29, No. 4, 08.2006, p. 395-398.

Research output: Contribution to journalArticle

Sinibaldi, VJ, Elza-Brown, K, Schmidt, J, Eisenberger, MA, Rosenbaum, E, Denmeade, SR, Pili, R, Walczak, J, Baker, SD, Zahurak, M & Carducci, MA 2006, 'Phase II evaluation of docetaxel plus exisulind in patients with androgen independent prostate carcinoma', American Journal of Clinical Oncology: Cancer Clinical Trials, vol. 29, no. 4, pp. 395-398. https://doi.org/10.1097/01.coc.0000225411.95479.b4
Sinibaldi, Victoria J. ; Elza-Brown, Kathy ; Schmidt, Jill ; Eisenberger, Mario A. ; Rosenbaum, Eli ; Denmeade, Samuel R. ; Pili, Roberto ; Walczak, Janet ; Baker, Sharyn D. ; Zahurak, Marianna ; Carducci, Michael A. / Phase II evaluation of docetaxel plus exisulind in patients with androgen independent prostate carcinoma. In: American Journal of Clinical Oncology: Cancer Clinical Trials. 2006 ; Vol. 29, No. 4. pp. 395-398.
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AU - Schmidt, Jill

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AU - Rosenbaum, Eli

AU - Denmeade, Samuel R.

AU - Pili, Roberto

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