Intravenous Vitamin C in Combination With Standard Chemotherapy for Pancreatic Cancer
May 1, 2025 updated by: Sidney Kimmel Cancer Center at Thomas Jefferson University
Phase I, Open Label, Dose Escalating Study of Intravenous Ascorbic Acid in Combination With Gemcitabine and Erlotinib in the Treatment of Metastatic 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Jefferson-Myrna Brind Center of Integrative Medicine
-
-
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.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intravenous Vitamin C
|
Gemcitabine (dose according to study protocol), Erlotinib (100 mg/day)
50 grams, 75 grams, or 100 grams of intravenous vitamin C, three times per week for 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Safety, assessed by toxicity (graded by NCI CTC), urinalysis, ECG, basic metabolic panel, CBC, and osmolality.
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Progression-free survival
Time Frame: 8 weeks
|
8 weeks
|
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 and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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 Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
August 4, 2009
First Submitted That Met QC Criteria
August 5, 2009
First Posted (Estimated)
August 7, 2009
Study Record Updates
Last Update Posted (Actual)
May 2, 2025
Last Update Submitted That Met QC Criteria
May 1, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Neoplasms by Site
- Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Tyrosine Kinase Inhibitors
- Antineoplastic Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Protein Kinase Inhibitors
- Erlotinib Hydrochloride
- Gemcitabine
Other Study ID Numbers
- 09D.99
- JT 1473 (Other Identifier: JeffTrial Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.