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

Brief summary public domain (ClinicalTrials.gov)

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).

Detailed description public domain (ClinicalTrials.gov)

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 in the control group will: * receive gemcitabine and nab-paclitaxel chemotherapy, which is standard for their cancer. * undergo imaging which is standard for their cancer and therapy. This can include CT scans, PET scans, and X-rays Participants in the intervention group 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.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Overall Survival [Every 2 months until death from any cause, up to approximately 69 months.]. Median, months (90% Confidence Interval). Ascorbate Group (n=18): 16 (8.6 to NA) [One-sided stratified log-rank test; Upper confidence interval not achieved due to an insufficient number of participants with events.]; Control (n=16): 8.3 (5.6 to NA) [One-sided stratified log-rank test; Upper confidence interval not achieved due to an insufficient number of participants with events.].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Progression Free Survival [Every 2 months to date of progression, up to approximately 69 months.]. Median, Months (90% Confidence Interval). Ascorbate Group (n=18): 6.2 (3.9 to NA) [One-sided stratified log-rank test; Upper confidence interval not achieved due to an insufficient number of participants with events.]; Control (n=16): 3.9 (2.3 to NA) [One-sided stratified log-rank test; Upper confidence interval not achieved due to an insufficient number of participants with events.].