Abstract

The Chemoprevention Branch of the Division of Cancer Prevention and Control at the National Cancer Institute has developed a program to identify and develop for human use drugs which will prevent or suppress the development of cancer. """"""""Cancer chemoprevention"""""""" refers to the prevention of invasive neoplasia with drugs. As part of this program, the Chemoprevention Branch is seeking to develop and validate intermediate endpoint biomarkers of cancer, i.e., precancerous biological and/or molecular changes in target epithelium that correlate with cancer biomarkers that can be modulated with a chemopreventive agent. Such intermediate endpoint biomarkers will significantly shorten the time required for clinical efficacy evaluation for promising chemopreventive agents. Progress in chemopreventive drug development is being seriously slowed by the lack of surrogate endpoint biomarkers (SEB) which can serve as earlier, shorter and less expensive substitutes for cancer incidence reduction on clinical trials. Phase 2 trials in chemoprevention evaluate safety and efficacy in the modulation of surrogate endpoint biomarkers of cancer.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
Division of Cancer Prevention And Control (NCI)
Type
Research and Development Contracts (N01)
Project #
N01CN075019-001
Application #
2600915
Study Section
Project Start
1997-02-15
Project End
2002-02-15
Budget Start
1997-06-27
Budget End
2002-02-15
Support Year
Fiscal Year
1997
Total Cost
Indirect Cost

  Institution

Name
University of California Irvine
Department
Type
DUNS #
161202122
City
Irvine
State
CA
Country
United States
Zip Code
92697

  Publications

Raj, K P; Zell, J A; Rock, C L et al. (2013) Role of dietary polyamines in a phase III clinical trial of difluoromethylornithine (DFMO) and sulindac for prevention of sporadic colorectal adenomas. Br J Cancer 108:512-8
Rial, Nathaniel S; Zell, Jason A; Cohen, Alfred M et al. (2012) Clinical end points for developing pharmaceuticals to manage patients with a sporadic or genetic risk of colorectal cancer. Expert Rev Gastroenterol Hepatol 6:507-17
Laukaitis, Christina M; Erdman, Steven H; Gerner, Eugene W (2012) Chemoprevention in patients with genetic risk of colorectal cancers. Colorectal Cancer 1:225-240
Zell, Jason A; Lin, Bruce S; Madson, Nikki et al. (2012) Role of obesity in a randomized placebo-controlled trial of difluoromethylornithine (DFMO) + sulindac for the prevention of sporadic colorectal adenomas. Cancer Causes Control 23:1739-44
Laukaitis, Christina M; Gerner, Eugene W (2011) DFMO: targeted risk reduction therapy for colorectal neoplasia. Best Pract Res Clin Gastroenterol 25:495-506
Zell, Jason A; McLaren, Christine E; Chen, Wen-Pin et al. (2010) Ornithine decarboxylase-1 polymorphism, chemoprevention with eflornithine and sulindac, and outcomes among colorectal adenoma patients. J Natl Cancer Inst 102:1513-6
Gerner, Eugene W; Meyskens Jr, Frank L (2009) Combination chemoprevention for colon cancer targeting polyamine synthesis and inflammation. Clin Cancer Res 15:758-61
Zell, Jason A; Pelot, Daniel; Chen, Wen-Pin et al. (2009) Risk of cardiovascular events in a randomized placebo-controlled, double-blind trial of difluoromethylornithine plus sulindac for the prevention of sporadic colorectal adenomas. Cancer Prev Res (Phila) 2:209-12
Meyskens Jr, Frank L; McLaren, Christine E; Pelot, Daniel et al. (2008) Difluoromethylornithine plus sulindac for the prevention of sporadic colorectal adenomas: a randomized placebo-controlled, double-blind trial. Cancer Prev Res (Phila) 1:32-8
McLaren, Christine E; Fujikawa-Brooks, Sharon; Chen, Wen-Pin et al. (2008) Longitudinal assessment of air conduction audiograms in a phase III clinical trial of difluoromethylornithine and sulindac for prevention of sporadic colorectal adenomas. Cancer Prev Res (Phila) 1:514-21

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