First Line Gemcitabine, Cisplatin and MEK162 in Advanced Biliary Tract Carcinoma

Exclusion Criteria

• •Any previous chemotherapy, biologic therapy, or investigational agent, except for adjuvant therapy as single agents and/or as radio-sensitizing agents limited to 5-fluorouracil and gemcitabine. Patient must have completed adjuvant therapy no less than six months prior to accrual.
• •Evidence of another active cancer that may influence patient outcome as determined by the Principal Investigator (PI) or co-Principal Investigator (co-PI), except for nonmelanoma skin carcinoma, melanoma in-situ, in-situ carcinoma of the cervix curatively treated, treated superficial bladder cancer, and adenocarcinoma of the prostate that has been surgically treated with a post-treatment PSA that is non-detectable.
• •Known brain metastases or primary central nervous system tumors with seizures that are not well controlled with standard medical therapy.
• •Uncontrolled intercurrent illness including, but not limited to psychiatric illness/social situations that would limit compliance with study requirements.
• •Known HIV positive patient
• •Significant cardiovascular disease including congestive heart failure (New York Heart Association Class II or higher) or active angina pectoris.
• •History of a myocardial infarction within 6 months.
• •History of a stroke or transient ischemic attack within 6 months.
• •Clinically significant peripheral vascular disease.
• •Major surgical procedure within 4 weeks.
• •Uncontrolled infection.
• •Known or suspected allergy to gemcitabine or cisplatin
• •Pregnant (positive pregnancy test)
• •Breast-feeding should be discontinued if a nursing mother is to be treated on clinical trial.
• •Any condition that impairs patient's ability to swallow whole pills
• •Malabsorption problem that may limit or inhibit the absorption of MEK 162
• •Patients with a history or current known evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO) or ophthalmopathy at baseline that would be considered a risk factor for CSR or RVO.
• •History of any organ or bone marrow transplant.