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Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer

This study has been terminated.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by:
Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:
NCT00193102
First received: September 12, 2005
Last updated: May 2, 2011
Last verified: May 2011
History of Changes

September 12, 2005
May 2, 2011
April 2001
February 2005   (final data collection date for primary outcome measure)
Overall response rate [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
  • Overall response rate
  • Time to disease progression
Complete list of historical versions of study NCT00193102 on ClinicalTrials.gov Archive Site
Not Provided
Safety of the combination regimen in this patient population.
Not Provided
Not Provided
 
Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer
Phase II Study of Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer

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.

Upon determination of eligibility, patients will be receive:

Thalidomide + Capecitebine
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Thalidomide
    Thalidomide
  • Drug: Capecitabine
    Capecitabine
Not Provided
Burris HA 3rd, Jones SF, Shipley D, Meluch AA, Greco FA, Barton JH, Yardley DA, Hainsworth JD. Phase II study of capecitabine in combination with thalidomide in patients with metastatic breast cancer. Cancer Invest. 2010 May;28(4):408-12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
June 2010
February 2005   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00193102
SCRI BRE 60
Not Provided
SCRI Oncology Research Consortium, SCRI
Sarah Cannon Research Institute
Celgene Corporation
Principal Investigator: Howard Burris, MD Sarah Cannon Research Institute
Sarah Cannon Research Institute
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP