Advanced or Metastatic CRC
Conditions
Keywords
Colorectal Cancer
Brief summary
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
Interventions
DRUGHydroxytyrosol
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
Sponsors
The Methodist Hospital Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A subject will be eligible for inclusion in this study only if all the following criteria are met: 1. Male or female ≥18 years of age. 2. Histopathologically or cytologically confirmed advanced or metastatic CRC. 3. Patient who is eligible for first-line therapy for advanced or metastatic CRC, such as 5FU-based therapy. 4. Measurable disease per the RECIST v1.1. 5. Eastern Cooperative Oncology Group performance status of 0 or 1. 6. Life expectancy ≥6 months. 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. 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. \-
Exclusion criteria
Subjects must meet all the inclusion criteria listed above in Section 10.1 and none of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety, Toxicity, and Pharmacokinetic/Pharmacodynamic (PK/PD) Profile of HT in Combination with FOLFIRI/FOLFOX + Biologics | Through study completion, up to 2 years | Evaluation of safety profile, toxicity, and PK/PD parameters in patients receiving HT with 5FU-based therapy according to NCI CTCAE v5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) at 6 and 12 Months | 6 and 12 months post study drug initiation | Measurement of PFS at 6 months and 12 months, based on tumor assessment using RECIST v1.1 criteria. |
| Objective Response Rate (ORR) According to RECIST v1.1 | Through study completion, up to 2 years | Proportion of patients achieving partial response (PR) or complete response (CR) as per RECIST v1.1. |
Countries
United States
Contacts
CONTACTJennifer Garrett M Clinical Trials Manager, MSN
CONTACTKimberly Vu Clinical Research Nurse, BSN
STUDY_DIRECTORAbdullah Esmail, MD
Houston Methodist Neal Cancer Center
Outcome results
None listed