Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: A Phase 2 Trial of High-dose Ascorbate for Pancreatic Cancer

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). All subjects receive high-dose ascorbate in addition to the standard treatment.

Detailed description: 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 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: Inclusion Criteria:
  -  Pathologic diagnosis (cell samples, biopsy, brushing, surgical sample) of adenocarcinoma of the pancreas. The tissue sample can be from a metastatic location, like a lymph node.
  -  Metastatic or node positive disease
  -  A physician must deem the patient medically fit for chemotherapy
  -  The patient must have 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
  -  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
  -  A malignancy (cancer) within the past 5 years, other than non-melanoma skin cancers, ductal carcinoma in situ (DCIS) of the breast, or carcinoma in situ of the cervix or bladder.
  -  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
  If all of the above are met, the potential participant will receive a 15 gram challenge dose of ascorbate via intravenous infusion. This is the final screening procedure.

Relevance to patient case: not relevant