Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer | RxWiki

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.
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
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
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: Velcade Adriamycin
Study Arm (s)	Experimental: A

Recruitment Information[ + expand ][ + ]

Recruitment Status	Terminated
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
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

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