Thalidomide/estramustine/paclitaxel in metastatic androgen-independent prostate cancer

Paul Mathew, Christopher J. Logothetis, Pauline Y. Dieringer, Isan Chen, Lance C. Pagliaro, Benjamin N. Bekele, Xian Zhou, Danai D. Daliani

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Background: This is a phase I/II trial of thalidomide with estramustine and paclitaxel in men with androgen-independent prostate cancer (AIPC) who underwent previous chemotherapy. Patients and Methods: Men with progressive AIPC were treated with oral thalidomide (200 mg, 400 mg, or 600 mg daily), intravenous paclitaxel (100 mg/m2 over 3 hours on days 3 and 10), and oral estramustine (140 mg 3 times daily on days 1-5 and days 8-12) every 21 days. Results: Phase I: first cycle dose-limiting toxicity occurred in 0 of 3 patients at 200 mg thalidomide daily, 0 of 3 at 400 mg daily, and 1 of 3 at 600 mg daily (the designated maximum tolerated dose). Phase II: twenty-nine of 38 evaluable patients (76%; 95% confidence interval, 67%-87%) experienced a 50% decrease in prostate-specific antigen level. Five of 18 patients (28%) with measurable disease exhibited an objective response. Nine of 14 patients (64%) with disease refractory to previous taxane therapy had 50% decreases in prostate-specific antigen level. Grade 3/4 adverse events included neutro-penia (9 of 39 [23%]), fatigue (9 of 39 [23%]), dyspnea (8 of 39 [21%]), and thromboembolic events (7 of 39 [18%]). Cumulative dose-limiting toxicity rates were minimal (13%) with thalidomide at 200 mg daily. Conclusion: The profile of activity of thalidomide/paclitaxel/estramustine in taxane-refractory AIPC warrants further investigation.

Original languageEnglish (US)
Pages (from-to)144-149
Number of pages6
JournalClinical Genitourinary Cancer
Volume5
Issue number2
DOIs
StatePublished - 2006
Externally publishedYes

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Estramustine
Thalidomide
Paclitaxel
Androgens
Prostatic Neoplasms
Prostate-Specific Antigen
Maximum Tolerated Dose
Dyspnea
Fatigue
Confidence Intervals
Drug Therapy

Keywords

  • Angiogenesis
  • Immunomodulatory agent
  • Taxanes
  • Thromboembolic events

ASJC Scopus subject areas

  • Oncology
  • Urology

Cite this

Mathew, P., Logothetis, C. J., Dieringer, P. Y., Chen, I., Pagliaro, L. C., Bekele, B. N., ... Daliani, D. D. (2006). Thalidomide/estramustine/paclitaxel in metastatic androgen-independent prostate cancer. Clinical Genitourinary Cancer, 5(2), 144-149. https://doi.org/10.3816/CGC.2006.n.031

Thalidomide/estramustine/paclitaxel in metastatic androgen-independent prostate cancer. / Mathew, Paul; Logothetis, Christopher J.; Dieringer, Pauline Y.; Chen, Isan; Pagliaro, Lance C.; Bekele, Benjamin N.; Zhou, Xian; Daliani, Danai D.

In: Clinical Genitourinary Cancer, Vol. 5, No. 2, 2006, p. 144-149.

Research output: Contribution to journalArticle

Mathew, P, Logothetis, CJ, Dieringer, PY, Chen, I, Pagliaro, LC, Bekele, BN, Zhou, X & Daliani, DD 2006, 'Thalidomide/estramustine/paclitaxel in metastatic androgen-independent prostate cancer', Clinical Genitourinary Cancer, vol. 5, no. 2, pp. 144-149. https://doi.org/10.3816/CGC.2006.n.031
Mathew, Paul ; Logothetis, Christopher J. ; Dieringer, Pauline Y. ; Chen, Isan ; Pagliaro, Lance C. ; Bekele, Benjamin N. ; Zhou, Xian ; Daliani, Danai D. / Thalidomide/estramustine/paclitaxel in metastatic androgen-independent prostate cancer. In: Clinical Genitourinary Cancer. 2006 ; Vol. 5, No. 2. pp. 144-149.
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abstract = "Background: This is a phase I/II trial of thalidomide with estramustine and paclitaxel in men with androgen-independent prostate cancer (AIPC) who underwent previous chemotherapy. Patients and Methods: Men with progressive AIPC were treated with oral thalidomide (200 mg, 400 mg, or 600 mg daily), intravenous paclitaxel (100 mg/m2 over 3 hours on days 3 and 10), and oral estramustine (140 mg 3 times daily on days 1-5 and days 8-12) every 21 days. Results: Phase I: first cycle dose-limiting toxicity occurred in 0 of 3 patients at 200 mg thalidomide daily, 0 of 3 at 400 mg daily, and 1 of 3 at 600 mg daily (the designated maximum tolerated dose). Phase II: twenty-nine of 38 evaluable patients (76{\%}; 95{\%} confidence interval, 67{\%}-87{\%}) experienced a 50{\%} decrease in prostate-specific antigen level. Five of 18 patients (28{\%}) with measurable disease exhibited an objective response. Nine of 14 patients (64{\%}) with disease refractory to previous taxane therapy had 50{\%} decreases in prostate-specific antigen level. Grade 3/4 adverse events included neutro-penia (9 of 39 [23{\%}]), fatigue (9 of 39 [23{\%}]), dyspnea (8 of 39 [21{\%}]), and thromboembolic events (7 of 39 [18{\%}]). Cumulative dose-limiting toxicity rates were minimal (13{\%}) with thalidomide at 200 mg daily. Conclusion: The profile of activity of thalidomide/paclitaxel/estramustine in taxane-refractory AIPC warrants further investigation.",
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