High-Dose Vitamin C + Chemotherapy for Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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).
Will I have to stop taking my current medications?
You may need to stop taking certain medications if you join this trial. Specifically, if you are on warfarin, flecainide, methadone, amphetamines, quinidine, or chlorpropamide and cannot switch to another drug, you may not be eligible to participate.
Is the combination of high-dose Vitamin C and chemotherapy safe for treating pancreatic cancer?
The combination of nab-paclitaxel (Abraxane) and gemcitabine (Gemzar) has been used in treating pancreatic cancer and is generally considered to have manageable side effects, though it can cause peripheral neuropathy (nerve damage) and myelotoxicity (bone marrow suppression). Rare cases of congestive heart failure have been reported with this treatment. Safety data specifically for high-dose Vitamin C in combination with chemotherapy is not provided in the available research.12345
How is the High-Dose Vitamin C + Chemotherapy treatment for pancreatic cancer different from other treatments?
This treatment is unique because it combines high-dose Vitamin C with the standard chemotherapy drugs gemcitabine and nab-paclitaxel, which are already known to improve survival in pancreatic cancer. The addition of Vitamin C is being explored for its potential to enhance the effectiveness of chemotherapy.34678
What data supports the effectiveness of the drug combination of high-dose Vitamin C, Gemcitabine, and nab-paclitaxel for pancreatic cancer?
Research shows that the combination of nab-paclitaxel (a form of chemotherapy) and gemcitabine has demonstrated substantial clinical activity and improved survival in patients with advanced pancreatic cancer. This combination is considered a standard treatment option for metastatic pancreatic cancer.34569
Who Is on the Research Team?
Joseph J. Cullen, MD, FACS
Principal Investigator
University of Iowa
Are You a Good Fit for This Trial?
This trial is for adults with metastatic pancreatic adenocarcinoma who are recommended gemcitabine and nab-paclitaxel treatment. They must have a certain platelet count, acceptable kidney function, not be pregnant, use birth control, and cannot have had prior chemotherapy for metastatic disease or other recent treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive gemcitabine and nab-paclitaxel chemotherapy, with the intervention group also receiving high-dose ascorbate
Follow-up
Participants are monitored for safety and effectiveness after treatment, with life-long follow-up
What Are the Treatments Tested in This Trial?
Interventions
- Gemcitabine
- nab-paclitaxel
- Pharmacological ascorbate
Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Joseph J. Cullen
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
National Cancer Institute (NCI)
Collaborator
Holden Comprehensive Cancer Center
Collaborator
McGuff Pharmaceuticals, Inc.
Industry Sponsor