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XELOX for Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00204776
First received: September 12, 2005
Last updated: December 13, 2007
Last verified: September 2005
History of Changes
  Purpose

Both capecitabine and oxaliplatin have single agent activity in breast cancer. The combination has improved activity in other solid tumors. This study seeks to assess the activity of the combination in breast cancer.


Condition Intervention Phase
Metastatic Breast Cancer
 Drug: Capecitabine and Oxaliplatin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Phase II Trial of Capecitabine and Oxaliplatin 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:
  • Overall response rate

Secondary Outcome Measures:
  • Toxicity
  • Time to progression

Estimated Enrollment: 37
Study Start Date: March 2005
Study Completion Date: November 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • preserved organ function
  • good performance status
  • no more than one prior therapy
  • no active brain metastasis

Exclusion Criteria:

  • No prior capecitabine or oxaliplatin
  • no con-current therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00204776

Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Sanofi
Investigators
Principal Investigator: Sherry Morgan-Meadows University of Wisconsin, Madison
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00204776     History of Changes
Other Study ID Numbers: CO 04104, 2004-0340
Study First Received: September 12, 2005
Last Updated: December 13, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Oxaliplatin
Capecitabine
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013