A Phase II Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Kidney Neoplasms
Both
Kidney Neoplasms
Trial Information
A Phase II Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Efficacy of the combination of thalidomide and capecitabine in metastatic renal cell carcinoma.
Principal Investigator
Dr. Sandy Srinivas
Investigator Role:
Principal Investigator
Investigator Affiliation:
Stanford University
Authority:
United States: Institutional Review Board
Study ID:
RENAL0001
NCT ID:
NCT00226980
Start Date:
October 2002
Completion Date:
July 2006
Related Keywords:
- Kidney Neoplasms
- Neoplasms
- Carcinoma
- Carcinoma, Renal Cell
- Kidney Neoplasms
Name | Location |
|---|---|
| Stanford University School of Medicine | Stanford, California 94305-5317 |
