A Phase 2 Trial of High-dose Ascorbate for Pancreatic Cancer (PACMAN 2.1)
Completed · Phase 2
Conditions studied: Pancreatic Neoplasms, Cancer of Pancreas, Cancer of the Pancreas, Neoplasms, Pancreatic, Pancreas Cancer, Pancreas Neoplasms, Adenocarcinoma
In brief
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).
Key facts
- Study ID
- NCT02905578
- Run by
- University of Iowa
- People needed
- 40
- Starts
- 2018-11-28
- Expected to finish
- 2024-08-26
- Last updated by the study team
- 2026-07-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Holden Comprehensive Cancer Center — Iowa City, Iowa, United States
Full record on ClinicalTrials.gov
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