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Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer

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.
ClinicalTrials.gov Identifier: NCT00193102
Recruitment Status : Terminated
First Posted : September 19, 2005
Last Update Posted : May 3, 2011
Information provided by:

Study Description
Brief Summary:
The lack of non-overlapping toxicities between the two drugs, the ease of all oral drug administration, and the possibility for antitumor synergy make exploration of this combination regimen attractive in women with previously treated metastatic breast cancer. This phase II trial will be performed in collaboration with the Minnie Pearl Cancer Research Network, a multicenter, community-based clinical trials group.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Thalidomide Drug: Capecitabine Phase 2

Detailed Description:

Upon determination of eligibility, patients will be receive:

Thalidomide + Capecitebine

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer
Study Start Date : April 2001
Primary Completion Date : February 2005
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: Thalidomide
    Drug: Capecitabine

Outcome Measures

Primary Outcome Measures :
  1. Overall response rate [ Time Frame: 18 Months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

  • Metastatic breast cancer confirmed by biopsy
  • Measurable or evaluable disease
  • Females > 18 years
  • Able to perform activities of daily living with minimal assistance
  • Life expectancy > 3 months
  • Adequate bone marrow, liver and kidney function
  • All patients must give written informed consent in order to participate.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

  • Women who are pregnant or lactating.
  • Received more than 3 prior chemotherapy regimens in the metastatic setting.
  • Received continuous infusion 5-fluorouracil lasting > 120 hours.
  • Received thalidomide or capecitabine as their last prior regimen.
  • Preexisting moderate to severe neuropathy

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

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): NCT00193102

Sponsors and Collaborators
SCRI Development Innovations, LLC
Celgene Corporation
Principal Investigator: Howard Burris, MD SCRI Development Innovations, LLC
More Information

Additional Information:
Responsible Party: SCRI Oncology Research Consortium, SCRI
ClinicalTrials.gov Identifier: NCT00193102     History of Changes
Other Study ID Numbers: SCRI BRE 60
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: May 3, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors