Status:
TERMINATED
Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Celgene Corporation
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 attractiv...
Detailed Description
Upon determination of eligibility, patients will be receive: Thalidomide + Capecitebine
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00193102
Start Date
April 1 2001
End Date
June 1 2010
Last Update
May 3 2011
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