Phase I/II Cancer Chemoprevention Consortium

The University of Arizona Early Phase Chemoprevention Consortium led by Drs. Sherry Chow and David Alberts was awarded funding in September 2012 by the National Cancer Institute, Division of Cancer Prevention to conduct early-phase clinical trials to evaluate the safety, clinical activity, and biological effects of novel cancer preventive agents. This five-year award will total up to $9.6 million when fully funded.

The overall objective of this consortia program is to conduct multiple early phase clinical trials of NCI, DCP-sponsored cancer preventive agents. These early phase clinical trials will evaluate the potential of novel cancer preventive agents in individuals at risk for certain types of cancer which allow researchers to determine the clinical activity and biological effects of these agents to select promising agents for further clinical testing. These trials also allow researchers to determine potential biomarkers of carcinogenesis – the process of cancer development – and chemopreventive mechanisms.

The UA Early Phase Chemoprevention Consortium is one of just five nationally funded by this competitive award program. The UA Consortium received its first award in 2003 which supported 10 early phase clinical trials of various pharmaceutical and nutraceutical compounds in breast, cervical, prostate, melanoma and esophageal cancer prevention. UA College of Medicine researchers and clinicians from hematology and oncology, dermatology, urology, gastroenterology, gynecology, surgical oncology, pathology, and cellular and molecular medicine have led or participated in these studies.

The following is a list of trials conducted through the first award:

Completed Trials:
Phase 1b Sulindac Study for Women at High Risk for Breast Cancer (Protocol PI: Patricia Thompson, PhD).
Study results published in Cancer Prevention Research.

Phase II Trial of Polyphenon E for Cervical Cancer Prevention (Protocol PI: Francisco Garcia, MD); publication pending

Clinical Study of Resveratrol on Drug and Carcinogen Metabolizing Enzymes (Protocol PI: Sherry Chow, PhD).
Study results published in Cancer Prevention Research.

• Phase Ib Study of Polyphenon E in a Pre-prostatectomy Cohort (Protocol PI: Frederick Ahmann, MD).
Study results published in Cancer Prevention Research.

Phase II Trial of Sulindac in Individuals at Increased Risk for Melanoma (Protocol PI: Clara Curiel, MD).
Study results published in Cancer.

Resveratrol in Postmenopausal Women with High Body Mass Index (Protocol PI: Sherry Chow, PhD); publication pending

Pilot Study on the Bioactivity of Vitamin D in the Skin after Oral Supplementation (Protocol PI: Clara Curiel, MD); publication pending

Ongoing Trials:
Phase II Study of Metformin in a Pre-prostatectomy Cohort (Protocol PI: Mitch Sokoloff, MD); Recruiting new patients

Clinical Study of Ursodeoxycholic Acid for Barrett’s Esophagus (Protocol PI: Bhaskar Banerjee, MD); Active, not recruiting

Phase I Dose-Finding Trial of Letrozole in Postmenopausal Women at High Risk for Breast Cancer (Protocol PI: Ana Mari Lopez, MD, MPH); Active, not recruiting

It is anticipated that the new award will support five or six early phase clinical trials and the consortium will continue to encourage collaboration among clinicians and researchers across the UA College of Medicine. The consortium also involves researchers at other institutions including the University of California Irvine, University of California San Diego, University of Southern California, Stanford University, University of North Carolina, Emory University, Ohio State University, and Southern Arizona VA Health Care System.

The following is a list of currently approved trials to be conducted through the new award:
• The Effect of Intermittent versus Continuous Dose Aspirin on Nasal Epithelium Gene Expression in Current Smokers (Protocol PI: Linda Garland, MD); not yet recruiting 

• Clinical Study of the Effect of Combined Treatment of Aspirin and Zileuton on Biomarkers of Tobacco-related Carcinogenesis in Current Smokers (Protocol PI: Linda Garland, MD); not yet recruiting