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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

August 11, 2010
August 22, 2010
September 2007
September 2009   (final data collection date for primary outcome measure)
Overall response rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT01182142
CRT-06.CAP
No
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