Status:
COMPLETED
A Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Celgene Corporation
Conditions:
Kidney Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the efficacy of the combination of thalidomide and capecitabine in metastatic renal cell carcinoma and also to determine the safety of the combination.
Eligibility Criteria
Inclusion
- Able to comprehend and sign an IRB approved Informed consent
- Willingness and ability to comply with the FDA-mandated S.T.E.P.S.® program.
- Male or female 18 years or older
- Willing to use contraception
- Pathologic diagnosis of renal cell carcinoma
- Bi-dimensionally measurable disease
- Evidence of disease progression prior to start of treatment
- Failed prior immunotherapy or unwilling/unable to receive prior immunotherapy
- Adequate hematologic data: ANC.1.5; platelets\>100x10\^9
- Adequate renal function: Creatinine clearance .50cc
- Adequate liver function: Alkaline phos \<3XULN AST/ALT \<3XULN T.Bili \<1.5XULN
- ECOG performance status 0-1
Exclusion
- Known brain metastases.
- Peripheral neuropathy.
- Pregnant and/ or lactating female.
- Unable to take a baby aspirin.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00226980
Start Date
October 1 2002
End Date
July 1 2006
Last Update
April 14 2009
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305