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

Joseph J. Cullen

Status and phase

Completed

Phase 1

Conditions

Pancreatic Neoplasms

Treatments

Drug: Gemcitabine with escalating ascorbic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT01049880

200804753

Details and patient eligibility

About

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.

Full 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).

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)