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

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.
ClinicalTrials.gov Identifier: NCT01182142
Recruitment Status : Completed
First Posted : August 16, 2010
Last Update Posted : August 24, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Metastatic Renal Cell Carcinoma Drug: Capecitabine Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Capecitabine in Metastatic Non-clear Cell Renal Cell Carcinoma Patients
Study Start Date : September 2007
Primary Completion Date : September 2009
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Capecitabine
All patients will receive capecitabine.
Drug: Capecitabine
1,250 mg/m2 orally twice a day, days 1-14


Outcome Measures

Primary Outcome Measures :
  1. Overall response rate [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Overall survival Progression-free survival [ Time Frame: 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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:
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
First Posted: August 16, 2010    Key Record Dates
Last Update Posted: August 24, 2010
Last Verified: August 2010

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
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents