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| Tracking Information | |||||
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| First Received Date ICMJE | January 24, 2003 | ||||
| Last Updated Date | September 15, 2009 | ||||
| Start Date ICMJE | November 2002 | ||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00052845 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Docetaxel, Estramustine, and Exisulind in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy | ||||
| Official Title ICMJE | A Phase II Study Of Estramustine, Docetaxel, And Exisulind (IND #64733) In Men With Hormone Refractory Prostate Cancer | ||||
| Brief Summary | RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Estramustine may fight prostate cancer by reducing the production of androgens. Exisulind 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 these therapies may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining estramustine with exisulind and docetaxel in treating patients who have metastatic prostate cancer that has not responded to hormone therapy. |
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| Detailed Description | OBJECTIVES:
OUTLINE: Patients receive oral estramustine 3 times daily on days 1-5, docetaxel IV over 1 hour on day 2, and oral exisulind twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 18 months. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label | ||||
| Condition ICMJE | Prostate Cancer | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | Dawson NA, Halabi S, Ou SS, Biggs DD, Kessinger A, Vogelzang N, Clamon GH, Nanus DM, Kelly WK, Small EJ, For Cancer And Leukemia Group B. A Phase II Study of Estramustine, Docetaxel, and Exisulind in Patients with Hormone- Refractory Prostate Cancer: Results of Cancer and Leukemia Group B Trial 90004. Clin Genitourin Cancer. 2008 Sep;6(2):110-6. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Gender | Male | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Canada, Puerto Rico | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00052845 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000258766, CALGB-90004 | ||||
| Study Sponsor ICMJE | Cancer and Leukemia Group B | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | December 2003 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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