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Docetaxel, Estramustine, and Thalidomide in Treating Patients With Prostate Cancer Previously Treated With Hormone Therapy Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Docetaxel, Estramustine, and Thalidomide in Treating Patients With Prostate Cancer Previously Treated With Hormone Therapy conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Docetaxel, Estramustine, and Thalidomide in Treating Patients With Prostate Cancer Previously Treated With Hormone Therapy Clinical research trials and Docetaxel, Estramustine, and Thalidomide in Treating Patients With Prostate Cancer Previously Treated With Hormone Therapy health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Docetaxel, Estramustine, and Thalidomide in Treating Patients With Prostate Cancer Previously Treated With Hormone Therapy. Docetaxel, Estramustine, and Thalidomide in Treating Patients With Prostate Cancer Previously Treated With Hormone Therapy Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Docetaxel, Estramustine, and Thalidomide in Treating Patients With Prostate Cancer Previously Treated With Hormone Therapy clinical trial. Human subjects often get the best healthcare available for their Docetaxel, Estramustine, and Thalidomide in Treating Patients With Prostate Cancer Previously Treated With Hormone Therapy condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Docetaxel, Estramustine, and Thalidomide in Treating Patients With Prostate Cancer Previously Treated With Hormone Therapy  Docetaxel, Estramustine, and Thalidomide in Treating Patients With Prostate Cancer Previously Treated With Hormone Therapy
Docetaxel, Estramustine, and Thalidomide in Treating Patients With Prostate Cancer Previously Treated With Hormone Therapy
For Condition: recurrent prostate cancer,adenocarcinoma of the prostate,stage 4 prostate cancer
Status: Recruiting
Sponsor(s): Whittingham Cancer Center ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RichardFrank, Study Chair, Whittingham Cancer Center
Whittingham Cancer Center *Recruiting*
Norwalk, Connecticut, 06856
United States
Recruiting Anthony Coscia 203-845-2121
Carl & Dorothy Bennett Cancer Center at Stamford Hospital *Recruiting*
Stamford, Connecticut, 06902
United States
Recruiting Salvatore Del Prete 203-325-2695
Saint Vincent Catholic Medical Centers - St. Vincent's Hospital Staten Island *Recruiting*
Staten Island, New York, 10310-1699
United States
Recruiting Thomas Forlenza 718-818-2952
Additional Information:
Study ID Numbers: CDR0000069081; NCI-V01-1681,NH-0139
Study Start Date:
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00046826
Other Adenocarcinoma Of The Prostate Studies:
1. Paclitaxel, Estramustine, and Thalidomide in Treating Patients With Progressive Metastatic Androgen-Independent Prostate Cancer
2. Docetaxel With or Without Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases
3. R115777 in Treating Patients With Progressive, Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
4. Radiation Therapy in Treating Patients With Bone Metastases From Breast or Prostate Cancer
5. Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Prostate Cancer
Related Studies:
Other adenocarcinoma of the prostate Clinical Trials
Other New York Clinical Trials
Other Staten Island Clinical Trials
Docetaxel, Estramustine, and Thalidomide in Treating Patients With Prostate Cancer Previously Treated With Hormone Therapy
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