Actively Recruiting
Phase I Trial of 5-Fluorouracil (5FU) -Based Therapy in Combination With Hydroxytyrosol (HT) in Patients With Advanced or Metastatic Colorectal Cancer
Led by The Methodist Hospital Research Institute · Updated on 2026-04-17
33
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Phase I Trial of 5-Fluorouracil (5FU) -Based Therapy in Combination With Hydroxytyrosol (HT) in Patients With Advanced or Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Histopathologically or cytologically confirmed advanced or metastatic colorectal cancer
- Eligible for first-line 5-fluorouracil-based therapy for advanced or metastatic colorectal cancer
- Measurable disease according to RECIST v1.1 criteria
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Life expectancy of 6 months or more
- Females of childbearing potential must agree to use birth control during the study and specified periods after last doses of certain treatments
- Sexually active males whose partners can become pregnant must agree to use birth control during the study and specified periods after last doses of certain treatments
You will not qualify if you...
- White blood cell count less than 3000 or neutrophil count 1500 cells/mm3 or less with Fy null phenotype
- Platelet count less than 100,000 cells/mm3
- Hemoglobin less than 9 g/dL (iron infusion allowed for iron deficiency anemia)
- Elevated liver enzymes exceeding defined multiples of the upper limits of normal depending on liver metastases
- Serum albumin level less than 2.8 g/dL
- Total bilirubin above 1.5 times upper limit of normal or greater than 1.5 mg/dL
- Prothrombin time or INR above 1.5 times upper limit of normal unless within therapeutic limits on anticoagulants
- Estimated glomerular filtration rate below 50 mL/min
- Positive pregnancy test, pregnant, or breastfeeding (for females)
- Other significant lab abnormalities affecting safety or study outcomes
- Serious or uncontrolled cardiac conditions including arrhythmia, bradycardia, tachycardia, symptomatic valvular disease, class III/IV heart failure, or unstable angina
- Myocardial infarction within the past 6 months
- Active bleeding or platelet count under 100,000
- Persistent or chronic constipation, bowel obstruction, or fecaloma in past 6 months
- Chronic corticosteroid use over 5 mg prednisone daily or other immunosuppressants
- Known or uncontrolled hepatitis B, hepatitis C, or HIV infection
- History of galactose intolerance or related disorders
- Recent live attenuated vaccine or close contact with vaccine recipient within 1 month
- Use of investigational agents within past 30 days
- Use of protein or antibody-based therapies within past 3 months
- Unable to swallow oral capsules
- Microsatellite instability-high or deficient mismatch repair tumors
- Surgery within past 12 months
- For bevacizumab treatment: history of gastrointestinal fistula or perforation, recent major surgery, hemorrhage, thromboembolic events in past 6 months, uncontrolled hypertension, proteinuria, or hemoptysis
AI-Screening
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Trial Site Locations
Total: 1 location
1
Houston Methodist.
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Jennifer Garrett M Clinical Trials Manager, MSN
CONTACT
K
Kimberly Vu Clinical Research Nurse, BSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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