a phase 2 trial of high-dose ascorbate for pancreatic cancer (pacman 2.1)

Conditions: Pancreatic Neoplasms; Cancer of Pancreas; Cancer of the Pancreas; Neoplasms, Pancreatic; Pancreas Cancer; Pancreas Neoplasms; Adenocarcinoma

Summary: this clinical trial adds high-dose ascorbate (vitamin c) to the standard of care regimen for metastatic pancreatic adenocarcinoma (a type of pancreatic cancer). subjects are randomized between a control group (standard treatment) and an intervention group (pharmacologic ascorbate in addition to the standard treatment).

one of the standard treatments for metastatic pancreatic adenocarcinoma is nab-paclitaxel with gemcitabine. this standard therapy administers chemotherapy once per week for three weeks; patients then get a 'rest week' to complete the cycle (1 cycle = 4 weeks). this study adds 75 grams of ascorbate (vitamin c, sometimes called pharamcological ascorbate because the dose is so high) to standard therapy. the ascorbate is administered intravenously - through a vein in the arm. participants in the control group will: * receive gemcitabine and nab-paclitaxel chemotherapy, which is standard for their cancer. * undergo imaging which is standard for their cancer and therapy. this can include ct scans, pet scans, and x-rays participants in the intervention group will: * receive 75 grams of ascorbate 3 times per calendar week for each week of the chemotherapy cycle. * undergo imaging which is standard for their cancer and therapy. this can include ct scans, pet scans, and x-rays * provide blood samples to determine the biological effects, if any, the ascorbate has on the body during therapy. this active therapy portion lasts until the disease progresses and a new treatment needs to be adopted - this can be months to years. if disease progresses, participants go back to standard follow-up for their caner and the new/additional therapy their doctors prescribe. however, it is very important we remain in contact with participants; they will have life-long follow-up for this study.

Eligibility criteria:
inclusion criteria: * pathologic diagnosis (cell samples, biopsy, brushing, surgical sample) of adenocarcinoma of the pancreas. cancer from the ampullae of vater is also eligible. the tissue sample can be from a metastatic location, like a lymph node. * metastatic or node positive disease * one cancer site, that did not receive radiation therapy, that is at least 1 cm in size when looking at it by ct scan (cat scan) * recommended to receive gemcitabine and nab-paclitaxel * failed initial therapy or be ineligible for definitive curative therapy (e.g., surgical excision, radiation therapy) * a platelet count of at least 100,000 cells per ml * a creatinine level of less than 1 1/2 times the upper limit of normal for the local lab test, or, a creatinine clearance of at least 60 ml/(min\*1.73m2) * not pregnant * commit to using birth control during the study (all participants) exclusion criteria: * prior chemotherapy to treat the metastatic disease * other therapy (including radiation) within the past 4 weeks * side effects from prior therapies that are still deemed moderate to severe by a physician * glucose-6-phosphate dehydrogenase (g6pd) deficiency * patients actively receiving insulin or who are currently recommended to receive insulin by a doctor * patients requiring daily finger-stick blood glucose measurements * patients who are on the following drugs and cannot have a substitution (or who decline the substitution): * warfarin * flecainide * methadone * amphetamines * quinidine * chlorpropamide * an active cancer, other than the pancreatic cancer, that requires treatment. * enrolled in another therapeutic clinical trial * uncontrolled, intercurrent illness * hiv positive individuals undergoing therapy due to known drug:drug interaction between antiretroviral drugs and high-dose ascorbate therapy * women who are nursing

Keywords: ascorbate vitamin c pharmacological ascorbate pharmacologic ascorbate ascorbic acid gemcitabine nab-paclitaxel gemzar abraxane