Trial of Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM)

Summary

The purpose of this study is to see if a treatment regimen with 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.

Conditions

• Pancreatic Cancer
• Pancreas Cancer
• Pancreatic Adenocarcinoma Resectable
• Pancreatic Ductal Adenocarcinoma
• Pancreas Metastases

Interventions

DRUG

High Dose Ascorbic Acid 25 g/m^2

2x per week IV infusion Normal Saline on days Day 1, 3, 8, 10, 15, and 17 of each 21-day cycle

DRUG

Nanoparticle Paclitaxel protein bound 125mg/m^2

30 minute IV infusions on days 1 and 8 repeated every 21 days

DRUG

Cisplatin 25mg/m^2

Via 500mL of Normal Saline over 60 minute IV infusion on days 1 and 8 repeated every 21 days

DRUG

Gemcitabine 1000mg/m^2

Via 500mL of Normal Saline over 30 minute IV infusion on days 1 and 8 repeated every 21 days

DRUG

High Dose Ascorbic Acid 37.5 g/m^2

2x per week IV infusion Normal Saline on days Day 1, 3, 8, 10, 15, and 17 of each 21-day cycle

DRUG

High Dose Ascorbic Acid 56.25 g/m^2

2x per week IV infusion Normal Saline on days Day 1, 3, 8, 10, 15, and 17 of each 21-day cycle

DRUG

High Dose Ascorbic Acid 75 g/m^2

2x per week IV infusion Normal Saline on days Day 1, 3, 8, 10, 15, and 17 of each 21-day cycle

Sponsors & Collaborators

• Stand Up To Cancer

  collaborator OTHER

• Cancer Research UK

  collaborator OTHER

• Lustgarten Foundation

  collaborator OTHER

• Translational Genomics Research Institute

  collaborator OTHER

• Princeton University

  collaborator OTHER

• Salk Institute for Biological Studies

  collaborator OTHER

• Cold Spring Harbor Laboratory

  collaborator OTHER

• Barts Cancer Institute

  collaborator OTHER

• University of Arizona

  collaborator OTHER

• Imaging Endpoints

  collaborator UNKNOWN

• HonorHealth Research Institute

  lead OTHER

Principal Investigators

• Gayle S Jameson, RN, MSN, ACNP-BC, AOCN · HonorHealth Research Institute

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-12-15

Primary Completion

2021-09-14

Completion

2023-09-06

FDA Drug

Yes

Countries

• United States

Study Locations