RO4929097 Before Surgery in Treating Patients With Pancreatic Cancer

You may be eligible if

• Histologically or cytologically confirmed pancreatic adenocarcinoma
• * T1-3, N0-1, and M0 disease
• Surgically resectable disease confirmed by a surgeon experienced in pancreatic surgery
• * No borderline resectable disease defined as any of the following:
• * Tumors with severe unilateral or bilateral SMV/portal involvement impingement
• * Abutment (or) encasement of hepatic artery
• * SMA or celiac encasement (or) presence of SMV occlusion by tumor
• No metastatic disease
• ECOG performance status 0-1
• Life expectancy \> 6 months
• WBC ≥ 3,000/mm³
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9 g/dL
• Total bilirubin ≤ 2 mg/dL
• AST and ALT ≤ 2.5 times upper limit of normal
• Creatinine ≤ 2 mg/dL
• Calcium, magnesium, phosphorous, and potassium normal
• Negative pregnancy test
• Not pregnant or nursing
• Fertile patients must use effective barrier-method contraception 4 weeks before, during, and for ≥ 12 months after completion of treatment
• Able to swallow tablets
• No malabsorption syndrome or other condition that would interfere with intestinal absorption
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to gamma-secretase inhibitor RO4929097 or other agents used in the study
• No uncontrolled hypocalcemia, hypomagnesemia, hyponatremia, hypophosphatemia, or hypokalemia despite adequate electrolyte supplementation
• * Grade 1 hyponatremia with sodium ≤ 131 mg/dL is permissible
• No uncontrolled intercurrent illness including, but not limited to, any of the following:
• * Ongoing or active infection
• * Symptomatic congestive heart failure
• * Unstable angina pectoris
• * Cardiac arrhythmia other than chronic
• * Stable atrial fibrillation
• * Psychiatric illness/social situations that would limit compliance with study requirements
• No baseline QTcF \> 450 msec (male) or QTcF \> 470 msec (female)
• Patients with a prior cancer with evidence of active cancer are excluded from this study
• * Patients with a prior cancer are permitted to enter this study as long as there is no documented evidence of active malignancy
• No uncontrolled electrolyte abnormalities including hypocalcemia, hypomagnesemia, and hypokalemia
• No symptomatic congestive heart failure, unstable angina pectoris, and a history of torsades de pointes or other significant cardiac arrhythmias
• No requirement for antiarrhythmics or other medications known to prolong QTc
• No other concurrent anticancer agents or therapies
• Recovered to \< grade 2 toxicity related to prior therapy
• No prior chemotherapy or radiotherapy for pancreatic cancer
• No other concurrent investigational agents
• No concurrent medications with narrow therapeutic indices that are metabolized by cytochrome P450 (CYP450), including warfarin sodium (Coumadin®), ketoconazole, or grapefruit juice
• No concurrent strong inducers or inhibitors of CYP3A4
• No concurrent combination antiretroviral therapy for HIV-positive patients