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Docetaxel, Estramustine, and Thalidomide in Treating Patients With Androgen-Independent Metastatic Adenocarcinoma of the Prostate Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Docetaxel, Estramustine, and Thalidomide in Treating Patients With Androgen-Independent Metastatic Adenocarcinoma of the Prostate conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Docetaxel, Estramustine, and Thalidomide in Treating Patients With Androgen-Independent Metastatic Adenocarcinoma of the Prostate Clinical research trials and Docetaxel, Estramustine, and Thalidomide in Treating Patients With Androgen-Independent Metastatic Adenocarcinoma of the Prostate health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Docetaxel, Estramustine, and Thalidomide in Treating Patients With Androgen-Independent Metastatic Adenocarcinoma of the Prostate. Docetaxel, Estramustine, and Thalidomide in Treating Patients With Androgen-Independent Metastatic Adenocarcinoma of the Prostate Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Docetaxel, Estramustine, and Thalidomide in Treating Patients With Androgen-Independent Metastatic Adenocarcinoma of the Prostate clinical trial. Human subjects frequently get the finest healthcare available for their Docetaxel, Estramustine, and Thalidomide in Treating Patients With Androgen-Independent Metastatic Adenocarcinoma of the Prostate condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Docetaxel, Estramustine, and Thalidomide in Treating Patients With Androgen-Independent Metastatic Adenocarcinoma of the Prostate  Docetaxel, Estramustine, and Thalidomide in Treating Patients With Androgen-Independent Metastatic Adenocarcinoma of the Prostate
Docetaxel, Estramustine, and Thalidomide in Treating Patients With Androgen-Independent Metastatic Adenocarcinoma of the Prostate
For Condition: stage 4 prostate cancer,recurrent prostate cancer,adenocarcinoma of the prostate
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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 prostate cancer by stopping blood flow to the tumor. Combining thalidomide with chemotherapy 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 androgen-independentmetastaticadenocarcinoma (cancer) of the prostate.
Details: 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 1, 8, and 15, 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. PROJECTED ACCRUAL: A total of 33-60 patients will be accrued for this study within 11-20 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol 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 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AviRetter, Study Chair, National Cancer Institute (NCI)
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
Additional Information:
Study ID Numbers: CDR0000361758; NCI-04-C-0132
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00083005
Other Adenocarcinoma Of The Prostate Studies:
1. CCI-779 in Treating Patients With Prostate Cancer
2. Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
3. BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
4. Morphine Plus Marijuana in Treating Pain Caused by Bone Metastases in Patients With Breast or Prostate Cancer
5. SU5416 Plus Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
Related Studies:
Other adenocarcinoma of the prostate Clinical Trials
Other Maryland Clinical Trials
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Docetaxel, Estramustine, and Thalidomide in Treating Patients With Androgen-Independent Metastatic Adenocarcinoma of the Prostate
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