Phase III Trial of Gemcitabine, Curcumin and Celebrex in Patients With Metastatic Colon Cancer
Status:
Unknown status
Trial end date:
2007-03-01
Target enrollment:
Participant gender:
Summary
Colorectal cancer is a major health concern in the Western world with an estimated lifetime
risk of 5-6%. The goal of achieving effective cancer prevention is driven by the prediction
that CRC will become the leading cause of death (surpassing heart disease) in this decade,
with an estimated 1,000,000 new cases and over 500,000 deaths per year, worldwide. Despite
continuing advances in diagnosis and therapy, long-term survival rates have not improved
significantly over the last four decades. Nearly 50% of all CRC patients will die of the
disease. Preventive strategies offer the best hope, at least until our understanding of the
biology of cancer matures to the point where it can be implemented into therapy. The search
for new chemopreventive compounds with minimal toxicity raises particular interest in
phytochemicals.Curcumin (diferuloylmethane) is a natural compound derived from the rhizome of
Curcuma Longa, an East Indian plant, commonly called turmeric. It has been shown to possess
potent anti-inflammatory and anti-oxidative properties, for which it has a long history of
dietary use as a food additive. Curcumin has also a potent anti-proliferative effects against
a variety of cancer cell lines in vitro, which stem from its ability to modulate many
intracellular signal transduction pathways. Human phase I-II studies found curcumin to be
safe, and indicated no dose-limiting toxicity when taken by mouth at doses up to 10 g/day.
This data, together with the dismal therapeutic options available for colon cancer patients,
suggest that curcumin warrants investigation in this setting. The present study evaluates
gemcitabine in combination with curcumin and celecoxib for patients with colon cancer.