Status:
TERMINATED
Sunitinib and Capecitabine for First Line Colon Cancer
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
Pfizer
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00961571
Start Date
August 1 2009
End Date
March 1 2011
Last Update
February 12 2025
Active Locations (1)
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1
Lombardi Cancer Center at Georgetown University
Washington D.C., District of Columbia, United States, 20007