Docetaxel, Estramustine, and Thalidomide in Treating Patients With Prostate Cancer Previously Treated With Hormone Therapy

Study Overview
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Brief Summary
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RATIONALE: Thalidomide may stop the growth of prostate cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with thalidomide may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and estramustine with thalidomide in treating patients who have prostate cancer previously treated with hormone therapy.

Detailed Description
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OBJECTIVES: Determine the objective response rate in patients with hormone-refractory prostate cancer treated with docetaxel, estramustine, and thalidomide. Determine the safety and toxicity of this regimen in these patients. Determine the efficacy of this regimen for pain control in these patients. OUTLINE: Patients receive oral estramustine on days 1-3 and docetaxel IV over 1 hour on day 2 for 3 weeks. Treatment repeats every 4 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral thalidomide once daily beginning on day 1 and continuing for 1 year in the absence of disease progression or unacceptable toxicity. Patients are followed monthly until disease progression. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 1 year.

Official Title
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A Phase II Clinical Trial of Taxotere, Emcyt and Thalidomide (TET) for the Treatment of Hormone-Refractory Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: docetaxel
* Drug: estramustine phosphate sodium
* Drug: thalidomide


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Prior treatment with androgen ablation including: Orchiectomy OR Luteinizing hormone-releasing hormone (LHRH) therapy (e.g., leuprolide) Patients on leuprolide must continue to receive the drug Prior nonsteroidal antiandrogens (e.g., flutamide, bicalutamide, or nilutamide) required Metastatic disease with disease progression during androgen ablation, defined by at least 1 of the following: 2 consecutive increased prostate-specific antigen (PSA) levels measured at least 1 week apart More than 25% increase in bidimensionally measurable soft tissue metastases 20% increase in the sum of the baseline sum of longest diameter of measurable lesions Appearance of new lesions Appearance of new foci on a radionuclide bone scan PSA greater than 10 ng/dL Testosterone no greater than 50 ng/mL (castrate level) No CNS metastases PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 70-100% Life expectancy: More than 16 weeks Hematopoietic: WBC greater than 3,500/mm3 Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin at least 8 g/dL Hepatic: AST and/or ALT no greater than 2.5 times upper limit of normal (ULN) if alkaline phosphatase no greater than ULN OR Alkaline phosphatase no greater than 4 times ULN if AST/ALT no greater than ULN Bilirubin no greater than ULN Renal: Creatinine less than 2.2 mg/dL Cardiovascular: No myocardial infarction within the past 6 months No New York Heart Association class III or IV heart disease No history of arterial or venous thrombosis No cerebrovascular accident within the past year Pulmonary: No history of pulmonary embolism Other: Fertile patients must use effective contraception during and for 4 weeks after study No peripheral neuropathy grade 2 or greater No active infection No serious concurrent medical illness that would preclude study No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 No other prior or concurrent active malignancy within the past 2 years except non-melanoma skin cancers No other medical condition or reason that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for prostate cancer Endocrine therapy: See Disease Characteristics At least 4 weeks since prior flutamide (6 weeks for bicalutamide or nilutamide) and continued evidence of disease progression (rising PSA) Prior steroids for prostate cancer allowed No concurrent steroids except for pre-medication for docetaxel Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Other: No concurrent herbal supplements to treat prostate cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: docetaxel|nan|
|Drug: estramustine phosphate sodium|nan|
|Drug: thalidomide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate as measured by RECIST criteria and prostate-specific antigen (PSA) response 3 months, 6 months, and 1 year after treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and toxicity as measured by CTC toxicity grading at baseline and during every visit |  |  | 
| Effectiveness of taxotere, emcyt, and thalidomide in pain control as measured by the pain scale at baseline and during every visit |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer