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Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer

This study has been terminated.
(no additional funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00574236
First Posted: December 17, 2007
Last Update Posted: January 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • anti-tumor response [ Time Frame: every two cycles ]

Secondary Outcome Measures:
  • -toxicity -time to progression [ Time Frame: each cycle ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00574236     History of Changes
Other Study ID Numbers: 2004-0130
CO04101
First Submitted: December 13, 2007
First Posted: December 17, 2007
Last Update Posted: January 18, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Doxorubicin
Liposomal doxorubicin
Bortezomib
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action