Sunitinib and Capecitabine for First Line Colon Cancer
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|ClinicalTrials.gov Identifier: NCT00961571|
Recruitment Status : Terminated (Unanticipated side effects and futility)
First Posted : August 19, 2009
Results First Posted : April 21, 2017
Last Update Posted : April 21, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer||Drug: sunitinib and capecitabine||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-Center, Phase II Trial of Sunitinib and Capecitabine in First Line Treatment of Patients With Metastatic Colorectal Cancer|
|Study Start Date :||August 2009|
|Primary Completion Date :||March 2011|
|Study Completion Date :||March 2011|
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
- Progression-free Survival [ Time Frame: 24 months ]Progression-free survival (PFS) will be measured as the number of days between each patient's enrollment and his/her date of progression or date of death.
- Toxicity [ Time Frame: 24 months ]
- Overall Survival [ Time Frame: 2 years ]Overall survival (OS) will be measured as the number of days between each patient's enrollment and his/her date of death.
- Objective Response [ Time Frame: 8 weeks ]complete response, partial response or stable disease per RECIST criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|