Everolimus and OSI-906 for Patients With Refractory Metastatic Colorectal Cancer

Exclusion Criteria

• •Patients who have received any cancer therapies \<4 weeks or 5 half lives (whichever is shorter) of initiating study therapy
• •Treatment with any investigational drug ≤ 4 weeks, or 5 half-lives of the drug, whichever is shorter
• •Patients who require coumadin for anticoagulation
• •Patients who have had major surgery or significant traumatic injury ≤4 weeks of the of study treatment
• •Minor surgery (with the exception of port placement) must be completed ≤ 7days prior to study therapy
• •Previous treatment with an IGFR inhibitor or MTOR Inhibitor
• •Chronic, systemic treatment with corticosteroids or another immunosuppressive agent
• •Patients with QTc interval \>450ms
• •Patients who require drugs that can prolong QTc.
• •Patients with congenital long QT syndrome, history of ventricular tachycardia, or ventricular fibrillation, or Torsades de Pointes with bradycardia.
• •Immunization with attenuated live vaccines within 1 week of beginning study therapy or during study period;Close contact to anyone that has received live virus vaccine should be avoided
• •Meningeal or brain metastasis
• •Other malignancies \< 3 years, with the exception of adequately treated basal or squamous cell carcinomas of the skin, or carcinoma in situ of the cervix
• •Patients with known HIV
• •Patients with positive testing for hepatitis B or C
• •Patients with risk factors for hepatitis must be tested for hepatitis viral loadHepatitis risk factors include the following:
• •Lived in Asia, Africa, Central and South America, Eastern Europe, Spain, Portugal, and Greece Any blood transfusions before 1990 Any IV drug use Any dialysis Household contact with a Hep B infected patient Mother had Hep B High-risk sexual activity Body piercing/tattoos
• •History suggestive of hepatitis B
• •Any severe or uncontrolled conditions that could affect their study participation such as:Severely impaired lung function;DCLO ≤ 50% of normal predicted value;O² Sat \<88% at rest on room air
• •Congestive Heart Failure of NYHA Class III or IV
• •Unstable angina, symptomatic CHF, MI ≤ 6 months, serious uncontrolled cardiac arrhythmia or any other clinically significant heart disease
• •CVA, TIA, angioplasty, or cardiac stenting \<12 months
• •Ventricular arrhythmia requiring medication
• •Known history of diabetes and/or patients who require ongoing use of insulin or oral anti-hyperglycemic therapy
• •Known liver disease
• •Impairment of GI function or gastrointestinal disease that in may significantly alter the absorption of study drugs
• •Concurrent treatment with drugs that are strong CYP3A4 inducers or moderate/strong CYP3A4 inhibitors
• •Concurrent treatment with drugs that are strong CYP1A2 inhibitors or inducers Women who are pregnant or breastfeeding.
• •Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements