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Investigator(s):
Shivaani Kummar, M.D., F.A.C.P. Principal Investigator Phone: 301-435-0517 Fax: 301-496-0826 kummars@mail.nih.gov
Referral Contact(s):
Janelle Bingham, R.N. Referral Coordinator Phone: 301-435-2715 Fax: 301-451-5433 jbingham@mail.nih.gov	Lemual Clayborn Referral Coordinator Phone: 301-451-0992 Fax: 301-496-0826 claybornlr@mail.nih.gov	Michelle Eugeni, R.N., B.S.N., O.C.N. Research Nurse Phone: 301-594-4325 Fax: 301-480-7281 meugeni@mail.nih.gov

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Key Eligibility Criteria:

• Histologically confirmed diagnosis of colorectal cancer that has progressed or recurred following oxaliplatin- and irinotecan-based chemotherapy
• KRAS mutation analysis results must be available prior to patient enrollment
• Disease amenable to biopsy and willingness to undergo pre- and post-treatment tumor biopsies
• Patients with known brain metastases or carcinomatous meningitis are excluded from this clinical trial, with the exception of patients whose brain metastatic disease status has remained stable for 4 weeks after treatment of the brain metastases, without steroids
• Able to swallow whole pills
• Absolute neutrophil count ≥ 1,500/microL
• Platelets ≥ 100,000/microL
• AST (SGOT)/ALT (SGPT) 3 x institutional upper limit of normal (ULN) or ≤ 5.0 institutional ULN if liver metastases
• No surgery, chemotherapy/biological therapy, or radiation therapy within 4 weeks of study treatment
• ECOG < 2
• No uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements
• No poorly controlled diabetes defined as fasting blood glucose of > 160 mg/dL (CTCAE Grade ≥ 2) or HgA1c > 8%

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Study Outline:

• Screening with a physical examination and medical history; imaging studies; and blood and urine samples to determine eligibility for the study
• MK-2206 by mouth once weekly and AZD6244 hydrogen by mouth once daily administered in 28-day cycles
• Cycles continue in the absence of disease progression or unacceptable toxicity
• Participation in the study also involves two biopsies, as well as periodic blood work and diagnostic imaging

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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.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/12/12
Updated: 10/2/12