Genistein in Treatment of Metastatic Colorectal Cancer
Status:
Completed
Trial end date:
2018-10-31
Target enrollment:
Participant gender:
Summary
Colorectal neoplasms are the third most common malignancies in the United States. Patients
with metastatic (stage IV) colorectal cancer have a median life expectancy of 2 years. The
response rates to chemotherapy range from 35-40%.
Epidemiologic evidence suggests that soy compounds may reduce the incidence of colorectal
cancers. Laboratory analyses demonstrate that genistein, a soy-derived compound, may inhibit
Wnt signaling, a pathway activated in majority of colorectal cancers. Laboratory observations
also demonstrate that genistein may augment growth inhibition when combined with
chemotherapeutic agents of 5-Fluorouracil and platinum compounds.
Based on pre-clinical data the investigators hypothesize that combining genistein with the
standard of care chemotherapeutic regimens will reduce chemotherapy resistance and improve
response rates in patients. The aim of the study is to add genistein to the regimens of
FOLFOX or FOLFOX-Avastin in patients with newly diagnosed stage IV colon or rectal neoplasms.