The Role of Meat-borne Carcinogens in Pancreatic Cancer

• Status: Withdrawn
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

We propose to recruit subjects scheduled for pancreatectomy as a treatment for pancreatic cancer. These subjects will ingest a very low dose of radiolabeled PhIP, a meat-derived carcinogen, and a small amount of resected tissue (waste) will be analyzed with highly sensitive technology to determine if this carcinogen binds to DNA in the pancreas.

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

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Collaborators: Lawrence Livermore National Laboratory; University of Arkansas

Criteria

Inclusion Criteria:

• At least 18 years old.

• Adequate hepatic function within 4 weeks of study enrollment defined as bilirubin ≤ 2 mg/dl and ALT, AST, and alkaline phosphatase ≤ 2 times the upper limit of normal.

• Females of childbearing potential or males whose partners are of child bearing potential are required to use an effective method of contraception (i.e., a hormonal contraceptive. intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the study and for 4 months after PhIP administration.

• Voluntary written informed consent (PhIP consent and Caffeine assay consent) before performance of any study-related procedure not part of normal medical care, with the understanding that the subject may withdraw consent at any time without prejudice to future medical care.

Exclusion Criteria:

• CA-19-9 equal to or above 400.

• Tumor size >3.5 cm.

• Fluid in the abdomen (ascites).

• Conditions present, which, in the opinion of the surgeon, could make resection difficult, e.g., extensive vascular involvement.

• Pregnant or lactating (for women).

• Uncontrolled cardiovascular disease; e.g. hypertension, angina, etc.

• Patients who are intolerant of a 200 mg dose of caffeine or who otherwise do not wish to participate in the caffeine assay when consent is sought for the primary consent will be considered refusers and will not be enrolled in the study.