A Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma

Kidney Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00226980
• Other study ID #: RENAL0001
• Secondary ID: RENAL0001
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: April 10, 2009
• Start date: October 2002
• Est. completion date: July 2006

Study information

• Verified date: April 2009
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2006
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms

Intervention

Drug:
• Thalidomide

• Capecitabine

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Celgene Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of the combination of thalidomide and capecitabine in metastatic renal cell carcinoma.
Secondary	Safety of the combination