- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00083005
Docetaxel, Estramustine, and Thalidomide in Treating Patients With Androgen-Independent Metastatic Adenocarcinoma of the Prostate
A Phase II Trial Combining Estramustine, Docetaxel And Thalidomide In Patients With Androgen-Independent Metastatic Prostate Cancer
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. Giving chemotherapy together with thalidomide may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel and estramustine together with thalidomide works in treating patients with androgen-independent metastatic adenocarcinoma (cancer) of the prostate.
Study Overview
Status
Conditions
Intervention / Treatment
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 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
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Bethesda, Maryland, United States, 20892
- NCI - Center for Cancer Research
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Toxicity
|
PSA response
|
Secondary Outcome Measures
Outcome Measure |
---|
Survival
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Avi S. Retter, MD, Eastchester Center for Cancer Care
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Leprostatic Agents
- Docetaxel
- Thalidomide
- Estramustine
Other Study ID Numbers
- 040132
- 04-C-0132
- CDR0000361758
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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