A Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma

Stanford University

Status and phase: Completed; Phase 2

Conditions: Kidney Neoplasms

Treatments: Drug: Thalidomide; Drug: Capecitabine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00226980

RENAL0001

NCT00226980

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)