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COMPLETED
NCT03410030
PHASE1/PHASE2

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

Sponsor: HonorHealth Research Institute

View on ClinicalTrials.gov

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.

Official title: Phase IB/II Trial of High Dose Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM) in Patients Who Have No Prior Therapy for Their Metastatic Pancreatic Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

17

Start Date

2017-12-15

Completion Date

2023-09-06

Last Updated

2026-07-23

Healthy Volunteers

No

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

Locations (1)

HonorHealth Research Institute

Scottsdale, Arizona, United States