OncoMatch/Clinical Trials/NCT06833866
Phase I Trial of 5-Fluorouracil (5FU) -Based Therapy in Combination With Hydroxytyrosol (HT) in Patients With Advanced or Metastatic Colorectal Cancer
Is NCT06833866 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Hydroxytyrosol for advanced or metastatic crc.
Treatment: Hydroxytyrosol — 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
Check if I qualifyExtracted eligibility criteria
Disease stage
Required: Stage IV
Metastatic disease required
advanced or metastatic CRC
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: investigational agent or study treatment
Receipt of any investigational agent or study treatment within the past 30 days
Cannot have received: protein or antibody-based therapeutic agents
Receipt of any protein or antibody-based therapeutic agents (e.g., growth hormones or monoclonal antibodies) within the past 3 months
Lab requirements
Blood counts
WBC <3000 and absolute neutrophil count ≤1500 cells/mm3 with the Fy null phenotype; platelets ≤100,000 cells/mm3; hemoglobin ≤9 g/dL
Kidney function
Estimated glomerular filtration rate <50 mL/min
Liver function
AST/ALT >5 × ULN if hepatic metastases; >2.5 × ULN if no liver metastases
Cardiac function
Any clinically significant and/or uncontrolled cardiac-related abnormality including arrhythmia, bradycardia, tachycardia, symptomatic valvular disease, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris; myocardial infarction within the past 6 months
Hematology laboratory values... Hepatic laboratory values... Estimated glomerular filtration rate <50 mL/min... Any clinically significant and/or uncontrolled cardiac-related abnormality... Myocardial infarction within the past 6 months
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Houston Methodist. · Houston, Texas
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