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A Research Trial of High Dose Vitamin C and Chemotherapy for Metastatic Pancreatic Cancer

NCT01049880 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-04-21

No results posted yet for this study

Summary

This study is designed to determine the maximum tolerated dose of vitamin C when given with a standard chemotherapy for people who have metastatic pancreatic cancer.

Conditions

  • Pancreatic Neoplasms

Interventions

DRUG

Gemcitabine with escalating ascorbic acid

Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic acid, given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbic acid per infusion Week 2: 25 grams ascorbic acid per infusion Week 3: 50 grams ascorbic acid per infusion Week 4: 75 grams ascorbic acid per infusion Week 5: 100 grams ascorbic acid per infusion Ascorbic acid infusion dose is maintained at the level that provides a serum level of 350-400 mg/dL.

Sponsors & Collaborators

  • University of Iowa

    collaborator OTHER

  • Holden Comprehensive Cancer Center

    collaborator OTHER

  • Joseph J. Cullen

    lead OTHER

Principal Investigators

  • Joseph J Cullen, M.D. · 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
2009-12-31
Primary Completion
2013-02-28
Completion
2013-03-31

Countries

  • United States

Study Locations

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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 NCT01049880 on ClinicalTrials.gov