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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
  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
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:

U.S. FDA Resources

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

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

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, RENAL0001
Study First Received: September 13, 2005
Last Updated: April 10, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 22, 2013