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| Tracking Information | |||||
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| First Received Date ICMJE | July 8, 2005 | ||||
| Last Updated Date | September 4, 2009 | ||||
| Start Date ICMJE | August 2005 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Prostate-specific antigen (PSA) level response from baseline measured ≤ 7 days prior to study and then 4-6 weeks [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Prostate-specific antigen (PSA) level response from baseline measured ≤ 7 days prior to study and then 4-6 weeks | ||||
| Change History | Complete list of historical versions of study NCT00118092 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | 17-AAG in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy | ||||
| Official Title ICMJE | A Phase II Trial of 17-Allylamino-17-Demethoxygeldanamycin (17-AAG) In Patients With Hormone-Refractory Metastatic Prostate Cancer | ||||
| Brief Summary | RATIONALE: Drugs used in chemotherapy, such as 17-AAG, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well 17-AAG works in treating patients with metastatic prostate cancer that did not respond to previous hormone therapy. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a multicenter study. Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 additional courses of treatment beyond documentation of CR. After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 16-28 patients will be accrued for this study within 20 months. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Prostate Cancer | ||||
| Intervention ICMJE | Drug: tanespimycin | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Heath EI, Hillman DW, Vaishampayan U, Sheng S, Sarkar F, Harper F, Gaskins M, Pitot HC, Tan W, Ivy SP, Pili R, Carducci MA, Erlichman C, Liu G. A phase II trial of 17-allylamino-17-demethoxygeldanamycin in patients with hormone-refractory metastatic prostate cancer. Clin Cancer Res. 2008 Dec 1;14(23):7940-6. | ||||
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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 | December 2008 (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 | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00118092 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000433492, MAYO-MC0453, NCI-6651 | ||||
| Study Sponsor ICMJE | Mayo Clinic | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | August 2006 | ||||
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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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