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

Phase 2

Completed

• Conditions: Metastatic Renal Cell Carcinoma
• Interventions: Drug: Capecitabine

• Registration Number: NCT01182142
• Lead Sponsor: Kidney Cancer Research Bureau

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2009-09
• Status Verified: 2010-08
• Study Completion: 2010-08
• Study First Submitted: 2010-08-11
• Study First Submitted QC: 2010-08-13
• Study First Posted: 2010-08-16
• Last Update Submitted: 2010-08-22
• Last Update Posted: 2010-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Capecitabine	Capecitabine	All patients will receive capecitabine.

Primary Outcome Measures

Name	Time	Method
Overall response rate	12 months

Secondary Outcome Measures

Name	Time	Method
Overall survival Progression-free survival	24 months

Trial Locations

Locations (1)

Natalia Petenko; 🇷🇺 Moscow, Russian Federation