Overview

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