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

August 22, 2010 updated by: Kidney Cancer Research Bureau

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

51

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival Progression-free survival
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kidney Cancer Research Bureau

Investigators

  • Principal Investigator: Lev Demidov, MD, D.Sc., N.N. Blokhin Russian Cancer Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

August 11, 2010

First Submitted That Met QC Criteria

August 13, 2010

First Posted (ESTIMATE)

August 16, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 24, 2010

Last Update Submitted That Met QC Criteria

August 22, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRT-06.CAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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