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Study of Capecitabine in Metastatic Non-clear Cell Renal Cell Carcinoma (RCC) Patients

This study has been completed.
Sponsor:
Information provided by:
Kidney Cancer Research Bureau
ClinicalTrials.gov Identifier:
NCT01182142
First received: August 11, 2010
Last updated: August 22, 2010
Last verified: August 2010
History of Changes
  Purpose

Capecitabine is an orally-administered chemotherapeutic agent used in the treatment of metastatic breast and colorectal cancers. The role of capecitabine in treatment of metastatic renal cell carcinoma is discussed. In this trial, we are evaluating efficacy of capecitabine in metastatic renal cell carcinoma patients.


Condition Intervention Phase
Metastatic Renal Cell Carcinoma
 Drug: Capecitabine
 Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Kidney Cancer Research Bureau:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival Progression-free survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 51
Study Start Date: September 2007
Study Completion Date: August 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Capecitabine
All patients will receive capecitabine.
 Drug: Capecitabine
1,250 mg/m2 orally twice a day, days 1-14

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically confirmed non-clear cell renal cell carcinoma
  • confirmed metastatic sites
  • no chemotherapy in history

Exclusion Criteria:

  • metastases in CNS
  • previous targeted therapy
  • other tumor
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01182142

Locations
Russian Federation
Natalia Petenko
Moscow, Russian Federation
Sponsors and Collaborators
Kidney Cancer Research Bureau
Investigators
Principal Investigator: Lev Demidov, MD, D.Sc. N.N. Blokhin Russian Cancer Research Center
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

No publications provided by Kidney Cancer Research Bureau

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Lev Demidov, N.N. Blokhin Russian Cancer Research Center
ClinicalTrials.gov Identifier: NCT01182142     History of Changes
Other Study ID Numbers: CRT-06.CAP
Study First Received: August 11, 2010
Last Updated: August 22, 2010
Health Authority: Russia: Ministry of Health and Social Development of the Russian Federation

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
 Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 17, 2012