Sunitinib and Capecitabine for First Line Colon Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: sunitinib and capecitabine
Intervention description: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily
Intervention MeSH terms: Capecitabine; Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: colorectal cancer; sunitinib; capecitabine

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.
    

Eligibility criteria:

        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