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

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.

Conditions

• Metastatic Pancreatic Cancer
• Pancreatic Cancer
• Pancreas Cancer
• Pancreatic Adenocarcinoma Resectable
• Pancreatic Ductal Adenocarcinoma
• Pancreatic Metastasis

Interventions

DRUG

Ascorbic Acid

25, 37.5, 56.25 or 75 grams/m2

DRUG

Paclitaxel protein-bound

125mg/m2 over 30 minute IV infusions on days 1 and 8 repeated every 21 days

DRUG

Cisplatin

25mg/m2 in 500 mL of NS over 60minute IV infusion on days 1 and 8 repeated every 21 days

DRUG

Gemcitabine

1000mg/m2 in 500 mL over 30 minute IV infusion on days 1 and 8 repeated every 21 days

Sponsors & Collaborators

• Cancer Research UK

  collaborator OTHER

• Stand Up To Cancer

  collaborator OTHER

• Lustgarten Foundation

  collaborator OTHER

• Destroy Pancreatic Cancer

  collaborator OTHER

• Translational Genomics Research Institute

  collaborator OTHER

• HonorHealth Research Institute

  collaborator OTHER

• Medical College of Wisconsin

  lead OTHER

Principal Investigators

• Ben George, MD · Medical College of Wisconsin

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-05-01

Primary Completion

2022-05-01

Completion

2023-05-01

FDA Drug

Yes

Countries

• United States

Study Locations