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A Phase II Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma

Phase 2
18 Years
Not Enrolling
Kidney Neoplasms

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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:


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


United States: Institutional Review Board

Study ID:




Start Date:

October 2002

Completion Date:

July 2006

Related Keywords:

  • Kidney Neoplasms
  • Neoplasms
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Stanford University School of Medicine Stanford, California  94305-5317