Gemcitabine Hydrochloride and Paclitaxel Albumin-Stabilized Nanoparticle Formulation With or Without Hydroxychloroquine Before Surgery in Treating Patients With Pancreatic Cancer

Inclusion Criteria

• Subjects with biopsy-proven potentially resectable or borderline adenocarcinoma of the pancreas as determined by National Comprehensive Cancer Network (NCCN) criteria
• Karnofsky performance status of 70-100%
• No active second malignancy except for basal cell carcinoma of the skin
• Absolute neutrophil count (ANC) >= 1.5 × 10^9/L
• Platelet count >= 100,000/mm^3 (100 × 10^9/L)
• Hemoglobin (Hgb) >= 9 g/dL
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]), alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 × upper limit of normal range (ULN)
• Total bilirubin =< ULN
• Serum creatinine =< 1.5mg/dl OR calculated creatinine clearance >= 50 for those patients with creatinine greater than 1.5
• Prothrombin time (PT) with normal limits (WNL); if patient is on warfarin for prophylactic clot presentation for indwelling catheter, PT/partial thromboplastin time (PTT) may be +/- 15 %
• PTT WNL; if patient on warfarin for prophylactic clot presentation for indwelling catheter, PT/PTT may be +/- 15 %
• Patient must be able to swallow enteral medications with no requirement for a feeding tube; patient’s must not have intractable nausea or vomiting which prohibits the patient from oral medications
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Subjects deemed surgically unresectable or subjects unwilling to undergo surgical resection
• Subjects who have received chemotherapy within 12 months prior to randomization
• Prior use of radiotherapy or investigational agents for pancreatic cancer
• Any evidence of metastasis to distant organs (liver, lung, peritoneum)
• Symptomatic evidence of gastric outlet obstruction
• Inability to adhere to study and/or follow-up procedures
• History of allergic reactions or hypersensitivity to the study drugs (hydroxychloroquine, gemcitabine, Abraxane)
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; all females of childbearing potential must have a blood test or urine study within two weeks prior to randomization to rule out pregnancy; should a woman become pregnant while participating in this study, she should inform her treating physician immediately; if a man impregnates a woman while participating in this study, he should inform his treating physician immediately as well
• Known human immunodeficiency virus (HIV)-positive patients are excluded from the study; for patients receiving combination anti-retroviral therapy; screening for HIV status will not be performed
• Patients with porphyria are ineligible
• Patients with psoriasis are ineligible unless the disease is well controlled and they are under the care of a specialist who agrees to monitor the patient for exacerbations
• Patients requiring the use of enzyme-inducing anti-epileptic medication that includes: phenytoin, carbamazepine, phenobarbital, primidone or oxcarbazepine are excluded
• Patients with previously documented macular degeneration or diabetic retinopathy are excluded
• Baseline electrocardiogram (EKG) with corrected QT interval (QTc) > 470 msec (including subjects on medication); subjects with ventricular pacemaker for whom QT interval is not measurable will be eligible on a case-by-case basis
• Patient with a history of interstitial lung disease, history of slowly progressive dyspnea, sarcoidosis, silicosis, idiopathic pulmonary fibrosis or pulmonary hypersensitivity pneumonitis
• Patient with known active infection with HIV, hepatitis B or hepatitis C
• Patients requiring use of warfarin for therapeutic purposes; subcutaneous heparin or fractionated heparin products are permitted if the goal is not to achieve full-dose systemic anticoagulation