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Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer

This study has been terminated.
(no additional funding)
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00574236
First received: December 13, 2007
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  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 Intervention Phase
Metastatic Breast Cancer
 Drug: PS-341, doxorubicin
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • anti-tumor response [ Time Frame: every two cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • -toxicity -time to progression [ Time Frame: each cycle ] [ Designated as safety issue: Yes ]

Enrollment: 4
Study Start Date: February 2006
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00574236

Locations
United States, Wisconsin
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
National Cancer Institute (NCI)
Millennium Pharmaceuticals, Inc.
Investigators
Principal Investigator: James A Stewart, M.D. University of Wisconsin PPC Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00574236     History of Changes
Other Study ID Numbers: 2004-0130, CO04101
Study First Received: December 13, 2007
Last Updated: January 16, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Doxorubicin
Bortezomib
 Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013