Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer
Overview[ - collapse ][ - ]
Purpose | Primary objective is to determine the effectiveness of the combination of bortezomib and doxorubicin in patients with metastatic breast cancer. The trial format is a single arm Phase II design wherein patients are treated with bortezomib IV on days 1, 4, 8, and 11 and with doxorubicin IV on days 1 and 8 of a 21-day cycle. |
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Condition | Metastatic Breast Cancer |
Intervention | Drug: PS-341, doxorubicin |
Phase | Phase 2 |
Sponsor | University of Wisconsin, Madison |
Responsible Party | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier | NCT00574236 |
First Received | December 13, 2007 |
Last Updated | January 16, 2013 |
Last verified | January 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | December 13, 2007 |
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Last Updated Date | January 16, 2013 |
Start Date | February 2006 |
Estimated Primary Completion Date | October 2009 |
Current Primary Outcome Measures | anti-tumor response [Time Frame: every two cycles] [Designated as safety issue: No] |
Current Secondary Outcome Measures | -toxicity -time to progression [Time Frame: each cycle] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
Brief Title | Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer |
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Official Title | A Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer |
Brief Summary | Primary objective is to determine the effectiveness of the combination of bortezomib and doxorubicin in patients with metastatic breast cancer. The trial format is a single arm Phase II design wherein patients are treated with bortezomib IV on days 1, 4, 8, and 11 and with doxorubicin IV on days 1 and 8 of a 21-day cycle. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Metastatic Breast Cancer |
Intervention | Drug: PS-341, doxorubicin bortezomib:1.3 mg/m2 IVP over 3-5 sec. days 1, 4, 8, 11 of 21 day cycle doxorubicin: 20 mg/m2 IV over 3-5 min. days 1,8 (one hour after bortezomib) of 21 day cycle Other Names:
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Study Arm (s) | Experimental: A |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Terminated |
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Estimated Enrollment | 4 |
Estimated Completion Date | October 2009 |
Estimated Primary Completion Date | October 2009 |
Eligibility Criteria | Inclusion Criteria: - Cytologically or histologically confirmed metastatic breast cancer - Measurable or evaluable disease - Age > 18, PS 0,1,2 - MUGA > 45% - Received one or fewer chemotherapies or investigational regimens for metastatic disease, no limit to the number of prior hormonal therapies. May have had single agent Herceptin and/or Herceptin plus single-agent chemotx. - Must meet designated laboratory criteria within 14 days of enrollment Exclusion Criteria: - Doxorubicin for metatstatic disease. - Pregnant or lactating. - Active infections, no myocardial infarction within 2 months of enrollment. - Investigational drugs within 14 days of enrollment. - Chemotherapy, radiotherapy, hormonal therapy or other investigational therapy within 4 weeks of enrollment. - Neuropathy that is > grade 2. - Active brain mets. - Hypersensitivity to bortezomib, boron, or mannitol. |
Gender | Female |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00574236 |
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Other Study ID Numbers | 2004-0130 |
Has Data Monitoring Committee | Yes |
Information Provided By | University of Wisconsin, Madison |
Study Sponsor | University of Wisconsin, Madison |
Collaborators | National Cancer Institute (NCI) Millennium Pharmaceuticals, Inc. |
Investigators | Principal Investigator: James A Stewart, M.D. University of Wisconsin PPC Comprehensive Cancer Center |
Verification Date | January 2013 |
Locations[ + expand ][ + ]
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin, United States, 53792 |
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