A Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma
Phase 2
Completed
- Conditions
- Kidney Neoplasms
- Registration Number
- NCT00226980
- Lead Sponsor
- Stanford University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- 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 Criteria
- Known brain metastases.
- Peripheral neuropathy.
- Pregnant and/ or lactating female.
- Unable to take a baby aspirin.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Efficacy of the combination of thalidomide and capecitabine in metastatic renal cell carcinoma.
- Secondary Outcome Measures
Name Time Method Safety of the combination
Trial Locations
- Locations (1)
Stanford University School of Medicine
🇺🇸Stanford, California, United States