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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00083005 |
Purpose
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.
Eligibility| 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
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CDR0000361758, NCI-04-C-0132 |
| Study First Received: | May 14, 2004 |
| Last Updated: | December 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00083005 History of Changes |
| Health Authority: | United States: Federal Government |
|
adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer |
|
Anti-Infective Agents Immunologic Factors Prostatic Diseases Genital Neoplasms, Male Thalidomide Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Estramustine Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms Hormones Docetaxel Anti-Bacterial Agents Neoplasms by Site |
Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Alkylating Agents Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Growth Substances Genital Diseases, Male Angiogenesis Inhibitors Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Antineoplastic Agents, Alkylating Adenocarcinoma |