A Phase 2 Trial of High-dose Ascorbate for Pancreatic Cancer (PACMAN 2.1)

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Joseph J. Cullen; University of Iowa
• Collaborators: Holden Comprehensive Cancer Center; McGuff Pharmaceuticals, Inc.; National Cancer Institute (NCI); National Institutes of Health (NIH)
• Treatments: Albumin-Bound Paclitaxel; Ascorbic Acid; Gemcitabine; Paclitaxel

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