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

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 concurr

Trial Details

NCT ID
NCT06833866
Phase
PHASE1
Sponsor
The Methodist Hospital Research Institute
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Hydroxytyrosol
Locations (sample)
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • A subject will be eligible for inclusion in this study only if all the following criteria are met:
  • Male or female ≥18 years of age.
  • Histopathologically or cytologically confirmed advanced or metastatic CRC.
  • Patient who is eligible for first-line therapy for advanced or metastatic CRC, such as 5FU-based therapy.

For full eligibility, visit ClinicalTrials.gov.

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