Phase II trial of cyclophosphamide, vincristine, and dexamethasone in the treatment of androgen-independent prostate carcinoma

Danai D. Daliani, Vasily Assikis, Shi Ming Tu, Christos N. Papandreou, Lance C. Pagliaro, Tammy Holtkamp, Xumei Wang, Peter F. Thall, Christopher J. Logothetis

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

BACKGROUND. In this Phase II study, the authors assessed the toxicity and antitumor activity of a combination of oral cyclophosphamide, oral low-dose dexamethasone, and intravenous vincristine (CVD) in patients with metastatic androgen-independent prostate carcinoma (AI-PCa). METHODS. Patients with histologic proof of adenocarcinoma of the prostate progressing despite adequate hormonal therapy and adequate organ function were treated with oral cyclophosphamide, 250 mg/daily (Days 1-14); intravenous vincristine, 1 mg daily (Days 1, 8, 15); and oral dexamethasone, 0.75 mg twice a day (Days 1-14) in 28-day cycles. Study endpoints were toxicity, rate of prostate specific antigen (PSA) decline > 50%, and/or measurable disease response. RESULTS. Fifty-two (95%) of 55 registered patients were evaluable. The majority (65%) of patients had received prior chemotherapy. The median number of treatment cycles given was two (range, one-seven cycles). Twenty-nine percent of the patients were found to have a > 50% decline in PSA level compared with baseline levels, and 25% of the patients with bidimensionally measurable soft-tissue or visceral disease were found to have a partial response. The median progressionfree survival duration was 10 weeks, and the median overall survival duration was 10.6 months. There were no thromboembolic events, and hematologic and nonhematologic toxicity was minimal. CONCLUSIONS. CVD was found to be an active and well-tolerated regimen for AI-PCa. The low toxicity profile makes CVD a useful treatment option for patients with significant comorbidities and high risk for treatment-related toxicity, especially thromboembolic events and myelotoxicity.

Original languageEnglish (US)
Pages (from-to)561-567
Number of pages7
JournalCancer
Volume97
Issue number3
DOIs
StatePublished - Feb 1 2003
Externally publishedYes

Fingerprint

Vincristine
Cyclophosphamide
Dexamethasone
Androgens
Prostate
Carcinoma
Prostate-Specific Antigen
Therapeutics
Survival
Comorbidity
Adenocarcinoma
Drug Therapy

Keywords

  • Androgen-independent
  • Cyclophosphamide
  • Dexamethasone
  • Prostate carcinoma
  • Vincristine (CVD)

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Daliani, D. D., Assikis, V., Tu, S. M., Papandreou, C. N., Pagliaro, L. C., Holtkamp, T., ... Logothetis, C. J. (2003). Phase II trial of cyclophosphamide, vincristine, and dexamethasone in the treatment of androgen-independent prostate carcinoma. Cancer, 97(3), 561-567. https://doi.org/10.1002/cncr.11078

Phase II trial of cyclophosphamide, vincristine, and dexamethasone in the treatment of androgen-independent prostate carcinoma. / Daliani, Danai D.; Assikis, Vasily; Tu, Shi Ming; Papandreou, Christos N.; Pagliaro, Lance C.; Holtkamp, Tammy; Wang, Xumei; Thall, Peter F.; Logothetis, Christopher J.

In: Cancer, Vol. 97, No. 3, 01.02.2003, p. 561-567.

Research output: Contribution to journalArticle

Daliani, DD, Assikis, V, Tu, SM, Papandreou, CN, Pagliaro, LC, Holtkamp, T, Wang, X, Thall, PF & Logothetis, CJ 2003, 'Phase II trial of cyclophosphamide, vincristine, and dexamethasone in the treatment of androgen-independent prostate carcinoma', Cancer, vol. 97, no. 3, pp. 561-567. https://doi.org/10.1002/cncr.11078
Daliani, Danai D. ; Assikis, Vasily ; Tu, Shi Ming ; Papandreou, Christos N. ; Pagliaro, Lance C. ; Holtkamp, Tammy ; Wang, Xumei ; Thall, Peter F. ; Logothetis, Christopher J. / Phase II trial of cyclophosphamide, vincristine, and dexamethasone in the treatment of androgen-independent prostate carcinoma. In: Cancer. 2003 ; Vol. 97, No. 3. pp. 561-567.
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abstract = "BACKGROUND. In this Phase II study, the authors assessed the toxicity and antitumor activity of a combination of oral cyclophosphamide, oral low-dose dexamethasone, and intravenous vincristine (CVD) in patients with metastatic androgen-independent prostate carcinoma (AI-PCa). METHODS. Patients with histologic proof of adenocarcinoma of the prostate progressing despite adequate hormonal therapy and adequate organ function were treated with oral cyclophosphamide, 250 mg/daily (Days 1-14); intravenous vincristine, 1 mg daily (Days 1, 8, 15); and oral dexamethasone, 0.75 mg twice a day (Days 1-14) in 28-day cycles. Study endpoints were toxicity, rate of prostate specific antigen (PSA) decline > 50{\%}, and/or measurable disease response. RESULTS. Fifty-two (95{\%}) of 55 registered patients were evaluable. The majority (65{\%}) of patients had received prior chemotherapy. The median number of treatment cycles given was two (range, one-seven cycles). Twenty-nine percent of the patients were found to have a > 50{\%} decline in PSA level compared with baseline levels, and 25{\%} of the patients with bidimensionally measurable soft-tissue or visceral disease were found to have a partial response. The median progressionfree survival duration was 10 weeks, and the median overall survival duration was 10.6 months. There were no thromboembolic events, and hematologic and nonhematologic toxicity was minimal. CONCLUSIONS. CVD was found to be an active and well-tolerated regimen for AI-PCa. The low toxicity profile makes CVD a useful treatment option for patients with significant comorbidities and high risk for treatment-related toxicity, especially thromboembolic events and myelotoxicity.",
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T1 - Phase II trial of cyclophosphamide, vincristine, and dexamethasone in the treatment of androgen-independent prostate carcinoma

AU - Daliani, Danai D.

AU - Assikis, Vasily

AU - Tu, Shi Ming

AU - Papandreou, Christos N.

AU - Pagliaro, Lance C.

AU - Holtkamp, Tammy

AU - Wang, Xumei

AU - Thall, Peter F.

AU - Logothetis, Christopher J.

PY - 2003/2/1

Y1 - 2003/2/1

N2 - BACKGROUND. In this Phase II study, the authors assessed the toxicity and antitumor activity of a combination of oral cyclophosphamide, oral low-dose dexamethasone, and intravenous vincristine (CVD) in patients with metastatic androgen-independent prostate carcinoma (AI-PCa). METHODS. Patients with histologic proof of adenocarcinoma of the prostate progressing despite adequate hormonal therapy and adequate organ function were treated with oral cyclophosphamide, 250 mg/daily (Days 1-14); intravenous vincristine, 1 mg daily (Days 1, 8, 15); and oral dexamethasone, 0.75 mg twice a day (Days 1-14) in 28-day cycles. Study endpoints were toxicity, rate of prostate specific antigen (PSA) decline > 50%, and/or measurable disease response. RESULTS. Fifty-two (95%) of 55 registered patients were evaluable. The majority (65%) of patients had received prior chemotherapy. The median number of treatment cycles given was two (range, one-seven cycles). Twenty-nine percent of the patients were found to have a > 50% decline in PSA level compared with baseline levels, and 25% of the patients with bidimensionally measurable soft-tissue or visceral disease were found to have a partial response. The median progressionfree survival duration was 10 weeks, and the median overall survival duration was 10.6 months. There were no thromboembolic events, and hematologic and nonhematologic toxicity was minimal. CONCLUSIONS. CVD was found to be an active and well-tolerated regimen for AI-PCa. The low toxicity profile makes CVD a useful treatment option for patients with significant comorbidities and high risk for treatment-related toxicity, especially thromboembolic events and myelotoxicity.

AB - BACKGROUND. In this Phase II study, the authors assessed the toxicity and antitumor activity of a combination of oral cyclophosphamide, oral low-dose dexamethasone, and intravenous vincristine (CVD) in patients with metastatic androgen-independent prostate carcinoma (AI-PCa). METHODS. Patients with histologic proof of adenocarcinoma of the prostate progressing despite adequate hormonal therapy and adequate organ function were treated with oral cyclophosphamide, 250 mg/daily (Days 1-14); intravenous vincristine, 1 mg daily (Days 1, 8, 15); and oral dexamethasone, 0.75 mg twice a day (Days 1-14) in 28-day cycles. Study endpoints were toxicity, rate of prostate specific antigen (PSA) decline > 50%, and/or measurable disease response. RESULTS. Fifty-two (95%) of 55 registered patients were evaluable. The majority (65%) of patients had received prior chemotherapy. The median number of treatment cycles given was two (range, one-seven cycles). Twenty-nine percent of the patients were found to have a > 50% decline in PSA level compared with baseline levels, and 25% of the patients with bidimensionally measurable soft-tissue or visceral disease were found to have a partial response. The median progressionfree survival duration was 10 weeks, and the median overall survival duration was 10.6 months. There were no thromboembolic events, and hematologic and nonhematologic toxicity was minimal. CONCLUSIONS. CVD was found to be an active and well-tolerated regimen for AI-PCa. The low toxicity profile makes CVD a useful treatment option for patients with significant comorbidities and high risk for treatment-related toxicity, especially thromboembolic events and myelotoxicity.

KW - Androgen-independent

KW - Cyclophosphamide

KW - Dexamethasone

KW - Prostate carcinoma

KW - Vincristine (CVD)

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