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Docetaxel, Estramustine, and Thalidomide in Treating Patients With Androgen-Independent Metastatic Adenocarcinoma of the Prostate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00083005
Recruitment Status : Completed
First Posted : May 17, 2004
Last Update Posted : March 15, 2012
National Cancer Institute (NCI)
Information provided by:
National Institutes of Health Clinical Center (CC)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as docetaxel and estramustine, work in different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of prostate cancer by stopping blood flow to the tumor. Giving chemotherapy together with thalidomide may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel and estramustine together with thalidomide works in treating patients with androgen-independent metastatic adenocarcinoma (cancer) of the prostate.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: docetaxel Drug: estramustine phosphate sodium Drug: thalidomide Phase 2

Detailed Description:



  • Determine the prostate-specific antigen response in patients with androgen-independent metastatic adenocarcinoma of the prostate treated with docetaxel, estramustine, and thalidomide.


  • Determine the survival duration in patients treated with this regimen.
  • Determine the pharmacokinetics of both docetaxel and thalidomide in patients treated with this regimen.
  • Determine whether any pharmacodynamic relationships exist between plasma concentrations of docetaxel and/or thalidomide and clinical activity or toxicity of this regimen in these patients.
  • Determine the existence of and quantification of circulating prostate cancer cells in patients before and after treatment with this regimen.
  • Determine genotype, with regard to cytochrome P450 2C19 polymorphism, in patients treated with this regimen.
  • Correlate genotype with pharmacokinetics and efficacy of this regimen in these patients.
  • Determine the changes in molecular markers of angiogenesis (including, but not limited to, serum and urine vascular endothelial growth factor) in patients before and after treatment with this regimen.
  • Determine the toxicity profile of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive docetaxel IV over 30 minutes on days 2, 9, and 16, oral thalidomide once daily on days 1-28, and oral estramustine three times daily on days 1-3, 8-10, and 15-17. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 33-60 patients will be accrued for this study within 11-20 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial Combining Estramustine, Docetaxel And Thalidomide In Patients With Androgen-Independent Metastatic Prostate Cancer
Study Start Date : March 2004
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Primary Outcome Measures :
  1. PSA response
  2. Toxicity

Secondary Outcome Measures :
  1. Survival

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the prostate

    • Metastatic disease
    • Androgen-independent disease
  • Clinically progressive disease documented by at least 1 of the following parameters:

    • Two consecutively rising prostate-specific antigen (PSA) levels taken at least 1 week apart

      • PSA ≥ 5.0 ng/mL
      • Continued rise in PSA 4 weeks after discontinuation of prior flutamide OR 6 weeks after discontinuation of prior bicalutamide or nilutamide (for patients treated with anti-androgen agents)
    • At least 1 new lesion on bone scan
    • Progressive measurable disease
  • Must have undergone bilateral surgical castration OR continue on a gonadotropin-releasing hormone agonist
  • No brain metastases



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3*
  • Hemoglobin ≥ 7.5 g/dL* NOTE: *No transfusions within the past 2 weeks


  • AST and ALT < 2.5 times upper limit of normal (ULN)
  • Bilirubin < ULN (≤ 3.0 times ULN for patients with Gilbert's syndrome)
  • Alkaline phosphatase ≤ 2.5 times ULN OR
  • Fractionated hepatic alkaline phosphatase ≤ 2.5 times ULN


  • Creatinine ≤ 1.5 mg/dL OR
  • Creatinine clearance ≥ 40 mL/min


  • No transient ischemic attacks or cerebrovascular accident within the past 2 years
  • No myocardial infarction within the past 6 months
  • No uncontrolled congestive heart failure
  • No uncontrolled angina pectoris
  • No thromboembolic disease


  • No peripheral neuropathy ≥ grade 2
  • No cognitive impairment that would preclude study participation or giving informed consent
  • No other active malignancy within the past 2 years except non-melanoma skin cancer or superficial bladder carcinoma
  • Fertile patients must use effective contraception for at least 1 month before, during, and for at least 1 month after study treatment


Biologic therapy

  • No prior thalidomide


  • No prior docetaxel
  • No prior estramustine
  • No prior chemotherapy for metastatic prostate cancer

Endocrine therapy

  • See Disease Characteristics


  • Recovered from prior radiotherapy


  • See Disease Characteristics
  • Recovered from prior surgery


  • No concurrent antiretroviral therapy for HIV-positive patients
  • No concurrent complementary or alternative therapy that would interact with study drugs
  • No concurrent herbal or nutritional products or dietary supplements that would interact with study drugs
  • No concurrent aprepitant as secondary prophylaxis or antiemetic treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00083005

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United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
NCI - Center for Cancer Research
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
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Study Chair: Avi S. Retter, MD Eastchester Center for Cancer Care
Layout table for additonal information Identifier: NCT00083005    
Obsolete Identifiers: NCT00078650
Other Study ID Numbers: 040132
First Posted: May 17, 2004    Key Record Dates
Last Update Posted: March 15, 2012
Last Verified: March 2012
Keywords provided by National Institutes of Health Clinical Center (CC):
adenocarcinoma of the prostate
recurrent prostate cancer
stage IV prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents, Alkylating
Alkylating Agents
Antineoplastic Agents, Hormonal