A Research Trial Of High Dose Vitamin C And Chemotherapy For Metastatic Pancreatic Cancer

Study Overview

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

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.

This is a phase I, dose-escalating study of ascorbic acid (vitamin C) designed to determine the maximum tolerated dose of vitamin C or, if well tolerated, the dose required to obtain a desired ascorbic acid plasma concentration. Because this is a phase I study, prospective subjects should have advanced disease (i.e., metastasis) and have failed other curative therapies (or, are unable to receive curative therapies due to comorbidities or stage of disease).

Pancreatic Neoplasms

DRUG: Gemcitabine with escalating ascorbic acid

200804753

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2010-01-14	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2017-04-19
First Submitted that Met QC Criteria 2010-01-14	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2017-04-21
First Posted (ACTUAL) 2010-01-15	Results First Posted N/A	Last Verified 2017-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Ascorbate	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 i

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Ascorbate

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 i

Primary Outcome Measures	Measure Description	Time Frame
Blood cell counts (neutropenia, thrombocytopenia) and serum chemistries (liver function tests, creatinine)		weekly

Secondary Outcome Measures	Measure Description	Time Frame
Plasma ascorbate level (targeted to 350 to 400 mg/dL)		Weekly
Survival		Ongoing

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Normal G6PD status
Histologically or cytologically diagnosed pancreatic adenocarcinoma.
Disease extent documented by CT scan (radiologically measurable disease is not required)
Ambulatory patient without evidence of spinal cord compression
No prior chemotherapy for metastatic disease
Failed curative therapy or patient ineligible for definitive curative therapy
Completed adjuvant therapy at least 4 weeks prior and recovered from any/all toxicities related to that treatment.
If post-therapy, must have disease progression since that treatment
If treated with prior radiation therapy, disease must be outside of the radiation fields
No currently active second malignancies unless it is a non-melanoma skin cancer
Women must be non-pregnant and non-lactating
ECOG performance of 0, 1, or 2
Granulocytes at least 1,500 / ul
Platelets at least 100,000 / ul
Creatinine less than 1.5 mg/dL or clearance of at least 60 mL / min
Total bilirubin less than 2 times the upper limit of normal
AST and ALT less than 3 times the upper limit of normal if liver metastases are not present. If liver metastases are present, AST and ALT less than 5 times the upper limit of normal
PT INR less than 1.5 (unless the patient is on full dose warfarin)
Patient must be at least 18 years of age
Patient must be able to understand consent process, the research study, and be able to sign the consent document

A psychiatric disorder by history or examination that would prevent completion of the study
ECOG performance of 3 or 4
Co-morbid conditions that affect survival: end stage congestive heart failure, unstable angina, myocardial infarction (within the past 6 weeks), uncontrolled blood sugars of greater than 300 mg/dL, known chronic active hepatitis or cirrhosis.
Consumption of excess alcohol (more than 4 drinks per day) or use of illicit drugs
Continued sse of over-the-counter antioxidants (supplements like vitamin C and grape seeds)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

University of Iowa
Holden Comprehensive Cancer Center

Investigators

PRINCIPAL_INVESTIGATOR: Joseph J Cullen, M.D., University of Iowa

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Welsh JL, Wagner BA, van't Erve TJ, Zehr PS, Berg DJ, Halfdanarson TR, Yee NS, Bodeker KL, Du J, Roberts LJ 2nd, Drisko J, Levine M, Buettner GR, Cullen JJ. Pharmacological ascorbate with gemcitabine for the control of metastatic and node-positive pancreatic cancer (PACMAN): results from a phase I clinical trial. Cancer Chemother Pharmacol. 2013 Mar;71(3):765-75. doi: 10.1007/s00280-013-2070-8. Epub 2013 Feb 5.

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Clinical Trial Record