Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer

This study has been terminated.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by:
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193102
First received: September 12, 2005
Last updated: May 2, 2011
Last verified: May 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: 18 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2001
Study Completion Date: June 2010
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Thalidomide
    Thalidomide
    Drug: Capecitabine
    Capecitabine
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
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, see Learn About Clinical Studies.

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

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

Additional Information:
Publications:
Responsible Party: SCRI Oncology Research Consortium, SCRI
ClinicalTrials.gov Identifier: NCT00193102     History of Changes
Other Study ID Numbers: SCRI BRE 60
Study First Received: September 12, 2005
Last Updated: May 2, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014