Sunitinib and Capecitabine for First Line Colon Cancer

Phase 2

Terminated

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
sunitinib and cepecitabine	sunitinib and capecitabine	Administration of sunitinib and capecitabine

Primary Outcome Measures

Name	Time	Method
Progression-free Survival	36 months	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.

Secondary Outcome Measures