A Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma

This study has been completed.
Celgene Corporation
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
First received: September 13, 2005
Last updated: April 10, 2009
Last verified: April 2009
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.

Condition Intervention Phase
Kidney Neoplasms
Drug: Thalidomide
Drug: Capecitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Efficacy of the combination of thalidomide and capecitabine in metastatic renal cell carcinoma.

Secondary Outcome Measures:
  • Safety of the combination

Estimated Enrollment: 30
Study Start Date: October 2002
Study Completion Date: July 2006
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00226980

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Celgene Corporation
Principal Investigator: Dr. Sandy Srinivas Stanford University
  More Information

No publications provided

Responsible Party: Sandy Srinivas, Principal Investigator, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00226980     History of Changes
Other Study ID Numbers: RENAL0001 
Study First Received: September 13, 2005
Last Updated: April 10, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Kidney Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on February 08, 2016