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Phase I Trial of 5-Fluorouracil (5FU) -Based Therapy in Combination With Hydroxytyrosol (HT) in Patients With Advanced or Metastatic Colorectal Cancer

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Jun 1, 2026 → Jun 1, 2028
See other at-risk trials from The Methodist Hospital Research Institute

Record History

  1. Primary completion pushed from Jun 1, 2026 to Jun 1, 2028 Primary endpoints: details revised at 1 of 1 entry · Completion pushed from Dec 1, 2027 to Dec 1, 2028 · Eligibility criteria expanded, about 36 words Show 3 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Completion pushed from Dec 1, 2027 to Dec 1, 2028
    • Eligibility criteria expanded, about 36 words
  2. Primary completion date: Jun 1, 2025 to Jun 1, 2026 Completion date: Dec 1, 2025 to Dec 1, 2027v2 Show 1 more changeShow less
    • Completion date: Dec 1, 2025 to Dec 1, 2027
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06833866
Lead Sponsor The Methodist Hospital Research Institute
Conditions Advanced or Metastatic CRC
Enrollment 33 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov