A Single-Center, Phase II Trial of Sunitinib and Capecitabine in First Line Treatment of Patients With Metastatic Colorectal Cancer
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival
2 years
No
Aiwu Ruth He, MD
Principal Investigator
Georgetown University
United States: Institutional Review Board
GA61822D
NCT00961571
August 2009
March 2011
Name | Location |
---|---|
Lombardi Cancer Center at Georgetown University | Washington, District of Columbia 20007 |