Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	NCI-04-C-0132 NCT00083005

Objectives

Primary

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

Secondary

1. Determine the survival duration in patients treated with this regimen.
2. Determine the pharmacokinetics of both docetaxel and thalidomide in patients treated with this regimen.
3. 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.
4. Determine the existence of and quantification of circulating prostate cancer cells in patients before and after treatment with this regimen.
5. Determine genotype, with regard to cytochrome P450 2C19 polymorphism, in patients treated with this regimen.
6. Correlate genotype with pharmacokinetics and efficacy of this regimen in these patients.
7. 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.
8. Determine the toxicity profile of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

Biologic therapy

• No prior thalidomide

Chemotherapy

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

Endocrine therapy

• See Disease Characteristics

Radiotherapy

• Recovered from prior radiotherapy

Surgery

• See Disease Characteristics
• Recovered from prior surgery

Other

• 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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count > 1,500/mm³
• Platelet count ≥ 100,000/mm³*
• Hemoglobin ≥ 7.5 g/dL*

 [Note: *No transfusions within the past 2 weeks]

Hepatic

• 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

Renal

• Creatinine ≤ 1.5 mg/dL

  OR

• Creatinine clearance ≥ 40 mL/min

Cardiovascular

• 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

Other

• 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

Expected Enrollment

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

Outcomes

PSA response
Toxicity

Survival

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.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Avi Retter, MD, Protocol chair		Ph: 718-732-4000; 888-807-9973

Related Information

Web site for additional information

Registry Information
Official Title		A Phase II Trial Combining Estramustine, Docetaxel And Thalidomide In Patients With Androgen-Independent Metastatic Prostate Cancer
Trial Start Date		2004-03-12
Trial Completion Date		2007-12-10
Registered in ClinicalTrials.gov		NCT00083005
Date Submitted to PDQ		2004-03-12
Information Last Verified		2007-02-05

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