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A Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma

This study has been completed.
Celgene Corporation
Information provided by:
Stanford University 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
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   (Adult, Senior)
Sexes Eligible for Study:   All
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 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

Responsible Party: Sandy Srinivas, Principal Investigator, Stanford University School of Medicine Identifier: NCT00226980     History of Changes
Other Study ID Numbers: RENAL0001
Study First Received: September 13, 2005
Last Updated: April 10, 2009

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors processed this record on May 25, 2017