Gemcitabine and Nab-Paclitaxel with or without Pharmacological Ascorbate in Treating Patients with Metastatic Pancreatic Cancer

Inclusion Criteria

• Must have cytological or histological diagnosis of adenocarcinoma arising in the pancreas. Adenocarcinoma arising from the Ampullae of Vater is eligible. Diagnosis from metastatic sampling is acceptable
• Disease must be metastatic or node positive
• Recommended to receive gemcitabine and nab-paclitaxel
• Patients must have measurable disease as per RECIST
• Failed initial therapy or ineligible for definitive curative therapy
• Age >= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky > 50%)
• Platelets >= 100,000/mm^3 (=< 14 days [d] of study day 1)
• Creatinine < 1.5 X institutional upper limit of normal OR creatinine clearance >= 60 mL/(min 1.73 m^2) for patients with creatinine levels above institutional normal (=< 14d of study day 1)
• Not pregnant. A pregnancy test will be obtained at screening per institutional policy
• Agree to birth control. 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. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Prior chemotherapy to treat metastatic pancreatic disease
• Adjuvant therapy (including radiation therapy) within 4 calendar weeks
• Toxicities from prior therapy for the malignancy should resolve to >= grade 2
• G6PD (glucose-6-phosphate dehydrogenase) deficiency
• Patients actively receiving insulin are excluded unless approved by the Investigational New Drug (IND) medical monitor, IND sponsor, and the study principal investigator (PI)
• Patients requiring daily finger-stick blood glucose measurements unless approved by the IND medical monitor, IND sponsor, and the study PI
• Patients who are on warfarin and cannot have a drug substitution or who decline the drug substitution
• Patients who are on the following drugs and cannot have a drug substitution: flecainide, methadone, amphetamines, quinidine, and chlorpropamide. High dose ascorbic acid may affect urine acidification and, as a result, may affect clearance rates of these drugs
• A concurrent malignancy that is clinically actionable or would impact the primary outcome of the clinical trial (a concurrent malignancy whose treatment does not have the potential to interfere with the safety or efficacy of the trial is included as well)
• Enrolled in another clinical trial with a targeted endpoint of treating the patient’s cancer (imaging and biological trials are acceptable)
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection (requiring an inpatient stay or would delay the start of therapy), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness/social situations, or any other condition that would limit compliance with study requirements as determined by study team members
• Human immunodeficiency virus (HIV)-positive individuals. High-dose ascorbate acid is a known CYP450 3A4 inducer, which results in lower serum levels of antiretroviral drugs. A clinical trial designed to address these interaction issues is more appropriate than this phase 2 study
• Lactating women: The risks of chemotherapy to a fetus/infant are well documented