Overview

Phase I Trial of 5-Fluorouracil (5FU) -Based Therapy in Combination With Hydroxytyrosol (HT) in Patients With Advanced or Metastatic Colorectal Cancer

Status:
RECRUITING

Trial end date:
2025-12-01

Target enrollment:

Participant gender:

Summary

This is a phase I study investigating the safety and antitumor activity of 5FU-based therapy (FOLFIRI/FOLFOX + Biologics) in combination with Hydroxytyrosol (HT) as a treatment for patients with advanced or metastatic colorectal cancer. Patients will receive: 1 capsule of HT 25 mg daily for 2 weeks before beginning 5FU-based therapy (FOLFIRI/FOLFOX + Biologics), 1 capsule of HT (25 mg) daily for 2 weeks while receiving the FOLFIRI/FOLFOX + Biologics, until sign of disease progression. The prescribed FOLFIRI/FOLFOX administer as: Irinotecan 180 mg/m intravenously (IV) over 90 minutes concurrently with Leucovorin 400 mg/m IV over 120 minutes, followed by Fluorouracil 400-500 mg/m IV bolus then 2400-3000 mg/m IV infusion over 4-6 hours with or without, the designated Biologics, a standard dose of Cetuximab or Bevacizumab will be administered in 2-week cycles until disease progression or un-tolerated toxicity

Phase:

PHASE1

Details

Lead Sponsor:

The Methodist Hospital Research Institute

Treatments:

3,4-dihydroxyphenylethanol
Folfox protocol