RecruitingPhase 1NCT06833866

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

Sponsor

The Methodist Hospital Research Institute

Enrollment

33 participants

Start Date

Dec 4, 2024

Study Type

INTERVENTIONAL

Conditions

Advanced or Metastatic CRC

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/m² intravenously (IV) over 90 minutes concurrently with Leucovorin 400 mg/m² IV over 120 minutes, followed by Fluorouracil 400-500 mg/m² IV bolus then 2400-3000 mg/m² 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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase I trial tests whether adding a natural compound called hydroxytyrosol (found in olive oil) to standard chemotherapy (5-FU-based regimens) is safe and potentially more effective for people with advanced or metastatic colorectal cancer. **You may be eligible if...** - You are 18 or older - You have been confirmed to have advanced or metastatic colorectal cancer - You are starting first-line treatment with 5-FU-based chemotherapy - You have measurable disease on imaging - You have a good performance status (able to care for yourself and perform daily activities) - You have a life expectancy of at least 6 months - You are willing to use effective birth control if applicable **You may NOT be eligible if...** - You have already received treatment for metastatic colorectal cancer - You have significant heart, liver, kidney, or other serious health problems - You are pregnant or breastfeeding - You are unable to take oral medication Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHydroxytyrosol

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/m² intravenously (IV) over 90 minutes concurrently with Leucovorin 400 mg/m² IV over 120 minutes, followed by Fluorouracil 400-500 mg/m² IV bolus then 2400-3000 mg/m² 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

Locations(1)

Houston Methodist.

Houston, Texas, United States

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NCT06833866