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Tracking Information | |||||||||
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First Received Date ICMJE | July 8, 2004 | ||||||||
Last Updated Date | April 14, 2009 | ||||||||
Start Date ICMJE | September 2004 | ||||||||
Current Primary Outcome Measures ICMJE |
Prostate-specific antigen (PSA) response defined as a 50% decline in PSA [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures ICMJE |
Prostate-specific antigen (PSA) response defined as a 50% decline in PSA | ||||||||
Change History | Complete list of historical versions of study NCT00087139 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 | Ixabepilone in Treating Patients With Metastatic Prostate Cancer | ||||||||
Official Title ICMJE | Phase II Study of a Weekly Schedule of BMS-247550 for Patients With Hormone Refractory Prostate Cancer | ||||||||
Brief Summary | RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well ixabepilone works in treating patients with metastatic prostate cancer that has not responded to previous hormone therapy. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (none vs 1 prior taxane-containing regimen vs 2 prior cytotoxic regimens). Patients receive ixabepilone IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 83 patients (27 for the no prior chemotherapy stratum; 27 each for the 2 prior cytotoxic chemotherapy regimens and prior docetaxel strata) will be accrued for this study within 8-22 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 | Drug: ixabepilone | ||||||||
Study Arms / Comparison Groups | |||||||||
Publications * | |||||||||
* 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 | Active, not recruiting | ||||||||
Estimated Enrollment ICMJE | 83 | ||||||||
Completion Date | |||||||||
Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
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 | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID ICMJE | NCT00087139 | ||||||||
Responsible Party | Robert L. Comis, ECOG Group Chair's Office | ||||||||
Study ID Numbers ICMJE | CDR0000372946, ECOG-E3803 | ||||||||
Study Sponsor ICMJE | Eastern Cooperative Oncology Group | ||||||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||
Investigators ICMJE |
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Information Provided By | National Cancer Institute (NCI) | ||||||||
Verification Date | February 2009 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |