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A Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00226980
First received: September 13, 2005
Last updated: April 10, 2009
Last verified: April 2009
History of Changes

September 13, 2005
April 10, 2009
October 2002
July 2005   (final data collection date for primary outcome measure)
Efficacy of the combination of thalidomide and capecitabine in metastatic renal cell carcinoma.
To determine the efficacy of the combination of thalidomide and capecitabine in metastatic renal cell carcinoma.
Complete list of historical versions of study NCT00226980 on ClinicalTrials.gov Archive Site
Safety of the combination
To determine the safety of the combination.
Not Provided
Not Provided
 
A Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma
A Phase II Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma

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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Neoplasms
  • Drug: Thalidomide
  • Drug: Capecitabine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2006
July 2005   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00226980
RENAL0001, RENAL0001
Not Provided
Sandy Srinivas, Principal Investigator, Stanford University School of Medicine
Stanford University
Celgene Corporation
Principal Investigator: Dr. Sandy Srinivas Stanford University
Stanford University
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP