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

This study has been completed.
Information provided by:
Kidney Cancer Research Bureau Identifier:
First received: August 11, 2010
Last updated: August 22, 2010
Last verified: August 2010
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
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

Resource links provided by NLM:

Further study details as provided by Kidney Cancer Research Bureau:

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

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

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


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01182142

Russian Federation
Natalia Petenko
Moscow, Russian Federation
Sponsors and Collaborators
Kidney Cancer Research Bureau
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 Identifier (NCT Number):
Responsible Party: Lev Demidov, N.N. Blokhin Russian Cancer Research Center Identifier: NCT01182142     History of Changes
Other Study ID Numbers: CRT-06.CAP
Study First Received: August 11, 2010
Last Updated: August 22, 2010

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on September 21, 2017