NCT00961571

Sunitinib and Capecitabine for First Line Colon Cancer

A Single-Center, Phase II Trial of Sunitinib and Capecitabine in First Line Treatment of Patients With Metastatic Colorectal Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is for patients with metastatic colorectal cancer who have not been treated with chemotherapy for their cancer. The purpose of this study is to find out if Capecitabine and Sunitinib can be used together to improve progression-free survival in colorectal cancer. All patients will take two medicines (Sunitinib and Capecitabine) by mouth every day until their cancer gets worse.

Detailed description

This is a single-center, open-label, one-arm study. Patients will be stratified by prior adjuvant therapy and ECOG performance status at study entry. In this study, we propose to obtain PET scans at baseline, 2 weeks, 8 weeks and 24 weeks from the initiation of treatment. Response at 2 weeks, 8 weeks and 24 weeks will be correlated to progression-free survival, overall survival and response according to RECIST criteria. We will collect plasma and urine samples from enrolled patients before and four weeks after sunitinib treatment. The samples will be analyzed and results correlated with patient clinical outcomes in order to explore the underlying mechanism of sunitinib induced hypertension.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	sunitinib and capecitabine	Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2009-08-19
• Last updated: 2025-02-12
• Results posted: 2017-04-21

Locations

1 site across 1 country: United States