Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer

Last updated: May 2, 2011
Sponsor: SCRI Development Innovations, LLC
Overall Status: Terminated

Phase

2

Condition

Breast Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT00193102
SCRI BRE 60
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

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 willdetermine if you meet all of the criteria. If you do not qualify for the trial, studypersonnel will explain the reasons. If you do qualify, study personnel will explain thetrial in detail and answer any questions you may have.

Study Design

Total Participants: 40
Study Start date:
April 01, 2001
Estimated Completion Date:
June 30, 2010

Study Description

Upon determination of eligibility, patients will be receive:

Thalidomide + Capecitebine