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A Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00226980
First Posted: September 27, 2005
Last Update Posted: April 14, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Celgene Corporation
Information provided by:
Stanford University
  Purpose
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: None (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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00226980


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

Responsible Party: Sandy Srinivas, Principal Investigator, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00226980     History of Changes
Other Study ID Numbers: RENAL0001
First Submitted: September 13, 2005
First Posted: September 27, 2005
Last Update Posted: April 14, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Capecitabine
Thalidomide
Antimetabolites, Antineoplastic
Antimetabolites
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


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