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

Phase 1

Completed

• Conditions: Pancreatic Neoplasms
• Interventions: Drug: Gemcitabine with escalating ascorbic acid

• Registration Number: NCT01049880
• Lead Sponsor: Joseph J. Cullen

Brief 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.

Detailed Description

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).

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-01-14
• Study First Submitted QC: 2010-01-14
• Study First Posted: 2010-01-15
• Primary Completion: 2013-02
• Study Completion: 2013-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ascorbate	Gemcitabine with escalating ascorbic acid	-

Primary Outcome Measures

Name	Time	Method
Blood cell counts (neutropenia, thrombocytopenia) and serum chemistries (liver function tests, creatinine)	weekly

Secondary Outcome Measures

Name	Time	Method
Survival	Ongoing
Plasma ascorbate level (targeted to 350 to 400 mg/dL)	Weekly

Trial Locations

Locations (1)

The University of Iowa Hospitals & Clinics; 🇺🇸 Iowa City, Iowa, United States