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Clinical Trial of High-dose Vitamin C for Advanced Pancreatic Cancer

NCT01515046 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2017-06-08

Study results available
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Summary

This is a phase II study. It is designed to provide information about if high-dose ascorbate (vitamin C) increases survival for pancreatic cancer patients. The hypothesis is that vitamin C is well tolerated and increases cancer treatment effectiveness, lengthening survival time for patients with advanced pancreatic cancer.

Conditions

Interventions

DRUG

Gemcitabine with escalating ascorbic acid

Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle) Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)

Sponsors & Collaborators

  • Susan L Bader Foundation of Hope

    collaborator UNKNOWN

  • Holden Comprehensive Cancer Center

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Joseph J. Cullen

    lead OTHER

Principal Investigators

  • Joseph J Cullen, MD · University of Iowa

  • Joseph J Cullen, MD · University of Iowa

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2015-07-31
Completion
2016-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01515046 on ClinicalTrials.gov