Phase I Trial of 5-Fluorouracil (5FU) -Based Therapy in Combination With Hydroxytyrosol (HT) in Patients With Advanced or Metastatic Colorectal Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Potwierdzony rozpoznanie zaawansowanego lub przerzutowego raka jelita grubego
- •Kwalifikacja do leczenia pierwszej linii chemioterapią 5FU
- •Mierzalne guzy w obrazowaniu
- •Dobry stan ogólny (możliwość aktywności codziennej)
- •Spodziewana przeżywalność co najmniej 6 miesięcy
- •Kobiety w wieku rozrodczym muszą używać antykoncepcji podczas badania i przez 30 dni po leczeniu
- •Mężczyźni muszą używać antykoncepcji, jeśli ich partnerka może zajść w ciążę
✗ Disqualifies
- •Zbyt niskie liczby białych krwinek lub płytek krwi
- •Zbyt niski poziom hemoglobiny
- •Znacznie podwyższone enzymi wątrobowe
- •Zbyt niski poziom albuminy we krwi
- •Podwyższony bilirubina we krwi
- •Zaburzenia krzepnięcia krwi
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- October 7, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Houston Methodist.
Houston, United States
Trial contact
Jennifer Garrett M Clinical Trials Manager, MSN
Kimberly Vu Clinical Research Nurse, BSN
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/8/2026.
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