Sunitinib and Capecitabine for First Line Colon Cancer

• Status: Terminated
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Georgetown University
• Collaborator: Pfizer
• Treatments: Capecitabine; Sunitinib

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