Sunitinib and Capecitabine for First Line Colon Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Drug: sunitinib and capecitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed, newly diagnosed metastatic colorectal cancer Measurable or evaluable disease in which surgical resection with curative intent is not possible No adjuvant chemotherapy within 6 months of enrollment No prior sunitinib or other receptor tyrosine kinase inhibitors 18 years of age or greater Anticipated survival of at least 6 months Ambulatory with an ECOG performance status of 0 or 1 and able to maintain weight Normal organ and marrow function Must agree to avoid pregnancy or fathering a child through out study participation Ability to understand and willingness to sign a written informed consent document Exclusion Criteria: Chemotherapy or radiotherapy within 6 months of enrollment Receiving any other investigational agents Known untreated brain metastases, uncontrolled seizure disorders, encephalitis, or multiple sclerosis Not able to ingest oral medications with normal absorption from the GI tract Uncontrolled hypertension History of severe/unstable angina, heart attack, congestive heart failure, transient ischemic attack, or stroke within 6 months of enrollment Cardiac dysrhythmias History of clinically significant bleeding within the past 6 months, including gross hemoptysis or hematuria, or underlying coagulopathy History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of study enrollment Current treatment with therapeutic doses of coumadin Concurrent malignancy other than colorectal cancer Known dihydropyrimidine dehydrogenase deficiency Uncontrolled intercurrent illness including ongoing or active infection or psychiatric illness that would limit compliance with study requirements. Pregnant and nursing women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sunitinib and cepecitabine<br>Administration of sunitinib and capecitabine | Drug: sunitinib and capecitabine<br>* Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily<br>* Other names: Capecitabine, Xeloda;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival | Progression-free survival (PFS) will be measured as the number of months between each patient's enrollment and his/her date of progression or date of death. | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, sunitinib, capecitabine