RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-12-04
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06833866

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female ≥18 years of age.
  2. 2. Histopathologically or cytologically confirmed advanced or metastatic CRC.
  3. 3. Patient who is eligible for first-line therapy for advanced or metastatic CRC, such as 5FU-based therapy.
  4. 4. Measurable disease per the RECIST v1.1.
  5. 5. Eastern Cooperative Oncology Group performance status of 0 or 1.
  6. 6. Life expectancy ≥6 months.
  7. 7. Females of childbearing potential must agree to use birth control during the study and for 30 days after your last dose of HT, at least 9 months after your last dose of oxaliplatin, at least 3 months after your last dose of 5-FU, and at least 6 months after your last dose of irinotecan.
  8. 8. Male who are sexually active and their partner can become pregnant, must agree to use birth control during the study and for 30 days after their last dose of HT, at least 6 months after their last dose of oxaliplatin, at least 3 months after his last dose of 5-FU, and at least 3 months after his last dose of irinotecan.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Jennifer Garrett M Clinical Trials Manager, MSN
CONTACT
281-222-9983
jmgarrett@houstonmethodist.org
Kimberly Vu Clinical Research Nurse, BSN
CONTACT
936-270-2037
kvu2@houstonmethodist.org

Principal Investigator

Abdullah Esmail, MD
STUDY_DIRECTOR
Houston Methodist Neal Cancer Center

Study Locations (Sites)

Houston Methodist.
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: The Methodist Hospital Research Institute

  • Abdullah Esmail, MD, STUDY_DIRECTOR, Houston Methodist Neal Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-04
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2024-12-04
Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

  • Colorectal Cancer

Additional Relevant MeSH Terms

  • Advanced or Metastatic CRC