Genistein in Treatment of Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title: Genistein Combined With FOLFOX or FOLFOX-Avastin for Treatment of Metastatic Colorectal Cancer: Phase I/II Pilot Study

Status Completed

Clinical Trial 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.

Clinical Trial Description

OBJECTIVES:

Primary

• Evaluate the tolerability of genistein when combined with chemotherapy

Secondary:

• Evaluate Response Rate (RR) as measured by the radiologic RECIST criteria

• Evaluate Progression Free Survival (PFS) ;

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms
• Colorectal Cancer
• Colorectal Neoplasms
• Rectal Cancer
• Rectal Neoplasms

• NCT number: NCT01985763
• Study type: Interventional
• Source: Icahn School of Medicine at Mount Sinai
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 2013
• Completion date: October 31, 2018