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

NCT03797443 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2019-05-31

No results posted yet for this study

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

Interventions

DRUG

Ascorbic Acid

Four escalating dose levels are planned in order to determine the MTD for Phase II The dose level for Phase II patients will be determined following completion of the Phase 1b study based on response from 3-6 patients receiving the designated dose level of ascorbic acid.

DRUG

nab paclitaxel

30 minute IV infusions on days 1 and 8 repeated every 21 days, followed by Cisplatin

DRUG

Cisplatin

60minute IV infusion on days 1 and 8 repeated every 21 days followed by Gemcitabine

DRUG

Gemcitabine

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

  • Piedmont Cancer Institute

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2022-01-31
Completion
2022-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03797443 on ClinicalTrials.gov