Kidney Neoplasms
Conditions
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.
Interventions
DRUGThalidomide
DRUGCapecitabine
Sponsors
Celgene Corporation
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of the combination of thalidomide and capecitabine in metastatic renal cell carcinoma. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of the combination | — |
Countries
United States
Outcome results
None listed