Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer

This study has been terminated.

First Received: September 12, 2005 Last Updated: August 13, 2007 History of Changes

Sponsors and Collaborators:	Sarah Cannon Research Institute Celgene Corporation
Information provided by:	Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:	NCT00193102

Purpose

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	Intervention	Phase
Breast Cancer	Drug: Thalidomide Drug: Capecitabine	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Thalidomide Capecitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer

Further study details as provided by Sarah Cannon Research Institute:

Primary Outcome Measures:

Overall response rate
Time to disease progression

Secondary Outcome Measures:

Safety of the combination regimen in this patient population.

Estimated Enrollment:	40
Study Start Date:	April 2001

Detailed Description:

Upon determination of eligibility, patients will be receive:

Thalidomide + Capecitebine

Eligibility

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193102

Sponsors and Collaborators

Sarah Cannon Research Institute

Celgene Corporation

Investigators

Principal Investigator:

Howard Burris, MD

Sarah Cannon Research Institute

More Information

No publications provided

Study ID Numbers:	SCRI BRE 60
Study First Received:	September 12, 2005
Last Updated:	August 13, 2007
ClinicalTrials.gov Identifier:	NCT00193102 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Antimetabolites
Anti-Bacterial Agents
Capecitabine
Immunologic Factors
Thalidomide

Skin Diseases
Breast Neoplasms
Angiogenesis Inhibitors
Immunosuppressive Agents
Breast Diseases

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Capecitabine
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Thalidomide
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Breast Neoplasms

Angiogenesis Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Anti-Bacterial Agents
Neoplasms
Neoplasms by Site
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Breast Diseases
Leprostatic Agents

ClinicalTrials.gov processed this record on May 07, 2009