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

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Joseph J. Cullen
• Collaborators: Holden Comprehensive Cancer Center; University of Iowa
• Treatments: Ascorbic Acid; Gemcitabine

Criteria

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)