CPN coordinates Phase I and Phase II clinical trials designed to prevent cancers of the breast, colon, esophagus, kidney, liver, lung, prostate, rectum, and skin. The purpose of a clinical trial is to determine the effectiveness and safety of different chemoprevention strategies.
Phase I chemoprevention trials are usually conducted in a small number of healthy participants to determine the best dose related to safety, agent effectiveness, and agent pharmacokinetic factors including absorption, distribution, metabolism, and excretion.
Phase II chemoprevention trials are conducted in larger groups of participants who are otherwise healthy but at risk for certain cancers to evaluate agent effectiveness in these individuals. Important objectives include identifying and validating biomarkers, signals to look for, as surrogate endpoints for cancer incidence.
Currently, there are four open and active clinical trials. Two are studies of lung cancer prevention in heavy smokers, one involving the study drug sulindac and the other involving the drug myo-inositol. The third is a study of the prevention of esophageal cancer in patients with Barrett's esophagus.
A fourth study opened earlier this year. It is a first-in-humans study of the new drug SR13668, which is similar to the active chemicals found in broccoli and other cruciferous vegetables. Our goal is to determine the type of capsule or tablet that will deliver the best dose of active ingredients to humans.
Studies for which CPN is in the process of developing concepts and research procedures include studies of skin, hepatobiliary, and breast cancer.
We are seeking healthy adults who might be at risk for the cancers mentioned above. If you would like to volunteer for one of these studies, please contact one of CPN's member organizations or CPN's Operations Office.