Status:
COMPLETED
Docetaxel, Estramustine, and Thalidomide in Treating Patients With Androgen-Independent Metastatic Adenocarcinoma of the Prostate
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 pros...
Detailed Description
OBJECTIVES: Primary * Determine the prostate-specific antigen response in patients with androgen-independent metastatic adenocarcinoma of the prostate treated with docetaxel, estramustine, and thali...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00083005
Start Date
March 1 2004
End Date
December 1 2007
Last Update
March 15 2012
Active Locations (2)
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1
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
2
NCI - Center for Cancer Research
Bethesda, Maryland, United States, 20892