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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01182142
First Posted: August 16, 2010
Last Update Posted: August 24, 2010
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.
Information provided by:
Kidney Cancer Research Bureau
August 11, 2010
August 16, 2010
August 24, 2010
September 2007
September 2009   (Final data collection date for primary outcome measure)
Overall response rate [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT01182142 on ClinicalTrials.gov Archive Site
Overall survival Progression-free survival [ Time Frame: 24 months ]
Same as current
Not Provided
Not Provided
 
Study of Capecitabine in Metastatic Non-clear Cell Renal Cell Carcinoma (RCC) Patients
Phase II Study of Capecitabine in Metastatic Non-clear Cell Renal Cell Carcinoma Patients
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Renal Cell Carcinoma
Drug: Capecitabine
1,250 mg/m2 orally twice a day, days 1-14
Experimental: Capecitabine
All patients will receive capecitabine.
Intervention: Drug: Capecitabine
Tsimafeyeu I, Demidov L, Kharkevich G, Petenko N, Galchenko V, Sinelnikov I, Naidzionak U. Phase II, multicenter, uncontrolled trial of single-agent capecitabine in patients with non-clear cell metastatic renal cell carcinoma. Am J Clin Oncol. 2012 Jun;35(3):251-4. doi: 10.1097/COC.0b013e31820dbc17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
August 2010
September 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
 
NCT01182142
CRT-06.CAP
No
Not Provided
Not Provided
Lev Demidov, N.N. Blokhin Russian Cancer Research Center
Kidney Cancer Research Bureau
Not Provided
Principal Investigator: Lev Demidov, MD, D.Sc. N.N. Blokhin Russian Cancer Research Center
Kidney Cancer Research Bureau
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP