Intravenous Vitamin C In Combination With Standard Chemotherapy For Pancreatic Cancer

Study Overview

Intravenous Vitamin C in Combination With Standard Chemotherapy for Pancreatic Cancer

Eligible candidates will be adults with metastatic pancreatic cancer (confirmed diagnosis with pathology reports and measurable computed tomography (CT) or magnetic resonance imaging (MRI)). Participants must not be receiving any other concurrent chemotherapy, or radiation therapy. Full inclusion/exclusion criteria are available. History and physical examination, and laboratory and imaging analyses will be done within 14 days prior to registration. The three cohorts of subjects will receive 50, 75 or 100 grams of intravenous ascorbic acid, three times per week for 8 weeks. Subjects will also have co-administration of the chemotherapy medications, gemcitabine (intravenously) and erlotinib (orally). Approximately 9 to 18 participants will be enrolled in this Phase I study.

N/A

Metastatic Pancreatic Cancer

DRUG: Gemcitabine and Erlotinib
DIETARY_SUPPLEMENT: Intravenous Vitamin C

09D.99
JT 1473 (OTHER Identifier) (OTHER: JeffTrial Number)

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 2009-08-04	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-05-01
First Submitted that Met QC Criteria 2009-08-05	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-05-02
First Posted (ACTUAL) 2009-08-07	Results First Posted N/A	Last Verified 2025-05

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: Intravenous Vitamin C	DRUG: Gemcitabine and Erlotinib Gemcitabine (dose according to study protocol), Erlotinib (100 mg/day) DIETARY_SUPPLEMENT: Intravenous Vitamin C 50 grams, 75 grams, or 100 grams of intravenous vitamin C, three times per week for 8 weeks.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Intravenous Vitamin C

DRUG: Gemcitabine and Erlotinib

Gemcitabine (dose according to study protocol), Erlotinib (100 mg/day)

DIETARY_SUPPLEMENT: Intravenous Vitamin C

50 grams, 75 grams, or 100 grams of intravenous vitamin C, three times per week for 8 weeks.

Primary Outcome Measures	Measure Description	Time Frame
Safety, assessed by toxicity (graded by NCI CTC), urinalysis, ECG, basic metabolic panel, CBC, and osmolality.		8 weeks

Secondary Outcome Measures	Measure Description	Time Frame
Progression-free survival		8 weeks

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:

Metastatic pancreatic cancer
Glucose 6 phosphate dehydrogenase status normal
ECOG performance status 0-2
Normal creatinine and transaminase
Women of child-bearing potential confirm negative pregnancy test

Concurrent chemotherapy or radiotherapy
Significant co-morbid disorders
Significant psychiatric symptoms
Prior treatment with gemcitabine
Concurrent chronic use of immunosuppressive agents (methotrexate, cyclosporine,corticosteroids)
Regular use of nonsteroidal anti-inflammatory agents
Smoking more than 1 pack per day
Excessive alcohol or drug use
Enrollment in other experimental therapy
Active infection
Patients experiencing ongoing response to recent treatments

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Daniel Monti, MD, MBA, Sidney Kimmel Cancer Center at Thomas Jefferson University

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

Monti DA, Mitchell E, Bazzan AJ, Littman S, Zabrecky G, Yeo CJ, Pillai MV, Newberg AB, Deshmukh S, Levine M. Phase I evaluation of intravenous ascorbic acid in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer. PLoS One. 2012;7(1):e29794. doi: 10.1371/journal.pone.0029794. Epub 2012 Jan 17.

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Resources

PatientS

Caregivers

Clinical Trial Record