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

Pancreas Cancer Clinical Trial

Official title: A Phase II Trial of Pharmacological Ascorbate, Gemcitabine, and Nab-Paclitaxel for Metastatic Pancreatic Cancer (PACMAN 2.1)

Status Active, not recruiting

Clinical Trial 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).

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Cancer of Pancreas
• Cancer of the Pancreas
• Neoplasms
• Neoplasms, Pancreatic
• Pancreas Cancer
• Pancreas Neoplasms
• Pancreatic Neoplasms

• NCT number: NCT02905578
• Study type: Interventional
• Source: University of Iowa
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 28, 2018
• Completion date: December 31, 2025