drugset / Trial / NCT03908333

High Dose Ascorbic Acid and Nanoparticle Paclitaxel Protein Bound and Cisplatin and Gemcitabine (AA NABPLAGEM) in Patients Who Have Metastatic Pancreatic Cancer

NCT03908333

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to see if a combination of paclitaxel protein bound (also known as nab-paclitaxel), gemcitabine, and cisplatin when given with high dose Ascorbic Acid will be safe and effective in individuals with untreated metastatic pancreatic cancer. Vitamin C is a nutrient found in food and dietary supplements. It protects cells and also plays a key role in making collagen (which provides strength and structure to skin, bones, tissues and tendons). High-dose vitamin C may be given by intravenous (IV) infusion (through a vein into the bloodstream) or orally (taken by mouth). When taken by intravenous infusion, vitamin C can reach much higher levels in the blood than when the same amount is taken by mouth. Some human studies of high-dose IV vitamin C in patients with cancer have shown improved quality of life, as well as improvements in physical, mental, and emotional functions, symptoms of fatigue, nausea and vomiting, pain, and appetite loss. Intravenous high-dose ascorbic acid has caused very few side effects in clinical trials.

Timeline

Start
2019-05-01
Primary completion
2022-05-01
Completion
2023-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 25 mg/m2 Intravenous
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject Paclitaxel Small molecule 125 mg/m2
Subject Vitamin C Other / unclassified 25000 mg/m2 Intravenous
Subject Vitamin C Other / unclassified 37500 mg/m2 Intravenous
Subject Vitamin C Other / unclassified 56250 mg/m2 Intravenous
Subject Vitamin C Other / unclassified 75000 mg/m2 Intravenous