Condition: Advanced or Metastatic CRC · Sponsor: The Methodist Hospital Research Institute
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
This description comes directly from the study's public registry record.
Jennifer Garrett M Clinical Trials Manager, MSN · 281-222-9983 · jmgarrett@houstonmethodist.org
Kimberly Vu Clinical Research Nurse, BSN · 936-270-2037 · kvu2@houstonmethodist.org
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| Houston Methodist. | Houston, Texas, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06833866