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Investigator(s):
Shivaani Kummar, M.D. Principal Investigator Phone: 301-435-5402 kummars@mail.nih.gov
Referral Contact(s):
Janelle Bingham, R.N. Referral Coordinator Phone: 301-435-2715 jbingham@mail.nih.gov	Laura D. Otten, R.N., B.S.N., O.C.N. Medical Oncology Referral Coordinator Phone: 301-451-1228 1-866-611-6310 (Toll Free) Fax: 301-480-0919 ottenl@mail.nih.gov	Sonja Crandon, R.N. Research Nurse Phone: 301-594-4325 Fax: 301-480-7281 crandons@mail.nih.gov

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Primary Eligibility:

• Histologically or cytologically confirmed metastatic colorectal cancer
• Evidence of disease recurrence or progression after one or more prior chemotherapy regimens for the treatment of metastatic disease
• Measurable disease
• At least one lesion amenable to biopsy (biopsies are optional)
• Expression in tumor cells of epidermal growth factor receptor (EGFR)
• Must have received or have declined one or more prior fluorouracil-containing combination chemotherapy regimens for metastatic disease
• No known brain metastasis
• Not eligible for or refused tumor resection
• No prior sorafenib or cetuximab
• Not pregnant or nursing
• Fertile patients must use effective contraception before, during, and for at least 2 months after completion of study treatment
• Able to swallow tablets

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Treatment Plan:

• Patients receive oral sorafenib twice daily on days 1-28 and cetuximab IV over 1-2 hours once a week on days 1, 8, 15 and 22; treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
• Blood samples are collected periodically and examined for biomarkers by enzyme immunoassay
• Tumor biopsy is obtained prior to treatment and after 4 weeks of treatment (optional)
• DCE-MRI scans are performed prior to treatment and after 8 weeks of treatment to evaluate tumor vascularity and metabolism
• After completion of study treatment, patients are followed for 4 weeks

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 8/22/08
Updated: 9/8/08