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 (Jun 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
Treatments studied
Other
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06833866 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior investigational agent or study treatment, protein or antibody-based therapeutic agents disqualifies patients from enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify