Completed

A Phase II Trial Combining Estramustine, Docetaxel And Thalidomide In Patients With Androgen-Independent Metastatic Prostate Cancer

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What is being tested

Data Collection

Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 2004
See protocol details

Summary

Principal SponsorNational Institutes of Health Clinical Center (CC)
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2004

Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the prostate-specific antigen response in patients with androgen-independent metastatic adenocarcinoma of the prostate treated with docetaxel, estramustine, and thalidomide. Secondary * 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.

Official TitleA Phase II Trial Combining Estramustine, Docetaxel And Thalidomide In Patients With Androgen-Independent Metastatic Prostate Cancer 
NCT00078650NCT00083005
Principal SponsorNational Institutes of Health Clinical Center (CC)
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesProstatic NeoplasmsUrogenital NeoplasmsMale Urogenital Diseases

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 PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * 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 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 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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, United StatesSee the location
Suspended

NCI - Center for Cancer Research

Bethesda, United States
Completed2 Study Centers