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

Primary Purpose

Metastatic Renal Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Capecitabine
Sponsored by
Kidney Cancer Research Bureau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Renal Cell Carcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Natalia Petenko

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Capecitabine

Arm Description

All patients will receive capecitabine.

Outcomes

Primary Outcome Measures

Overall response rate

Secondary Outcome Measures

Overall survival Progression-free survival

Full Information

First Posted
August 11, 2010
Last Updated
August 22, 2010
Sponsor
Kidney Cancer Research Bureau
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1. Study Identification

Unique Protocol Identification Number
NCT01182142
Brief Title
Study of Capecitabine in Metastatic Non-clear Cell Renal Cell Carcinoma (RCC) Patients
Official Title
Phase II Study of Capecitabine in Metastatic Non-clear Cell Renal Cell Carcinoma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kidney Cancer Research Bureau

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Renal Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
51 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Capecitabine
Arm Type
Experimental
Arm Description
All patients will receive capecitabine.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
1,250 mg/m2 orally twice a day, days 1-14
Primary Outcome Measure Information:
Title
Overall response rate
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Overall survival Progression-free survival
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lev Demidov, MD, D.Sc.
Organizational Affiliation
N.N. Blokhin Russian Cancer Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Natalia Petenko
City
Moscow
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
21358295
Citation
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.
Results Reference
derived
Links:
URL
http://www.ronc.ru/
Description
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Study of Capecitabine in Metastatic Non-clear Cell Renal Cell Carcinoma (RCC) Patients

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