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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00083005 |
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.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: docetaxel Drug: estramustine phosphate sodium Drug: thalidomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial Combining Estramustine, Docetaxel And Thalidomide In Patients With Androgen-Independent Metastatic Prostate Cancer |
Estimated Enrollment: | 60 |
Study Start Date: | March 2004 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
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
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Maryland | |
NCI - Center for Cancer Research | |
Bethesda, Maryland, United States, 20892 | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
Bethesda, Maryland, United States, 20892-1182 |
Study Chair: | Avi S. Retter, MD | Eastchester Center for Cancer Care |
Study ID Numbers: | CDR0000361758, NCI-04-C-0132 |
Study First Received: | May 14, 2004 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00083005 |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer |
Docetaxel Thalidomide Prostatic Diseases Genital Neoplasms, Male Estramustine Urogenital Neoplasms |
Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Anti-Infective Agents Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Angiogenesis Inhibitors Immunosuppressive Agents |
Pharmacologic Actions Anti-Bacterial Agents Neoplasms Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Alkylating Alkylating Agents Leprostatic Agents |