Sunitinib and Capecitabine for First Line Colon Cancer
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Single-Center, Phase II Trial of Sunitinib and Capecitabine in First Line Treatment of Patients With Metastatic Colorectal Cancer|
- Progression-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Objective Response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||August 2009|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Experimental: sunitinib and cepecitabine
Administration of sunitinib and capecitabine
Drug: sunitinib and capecitabine
Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00961571
|United States, District of Columbia|
|Lombardi Cancer Center at Georgetown University|
|Washington, District of Columbia, United States, 20007|
|Principal Investigator:||Aiwu Ruth He, MD||Georgetown University|