Actively Recruiting
5-Fluorouracil/Leucovorin (5FU/LV) in Combination With Regorafenib in Patients With Metastatic Colorectal Cancer
Led by The Methodist Hospital Research Institute · Updated on 2025-08-27
57
Participants Needed
1
Research Sites
238 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a non-inferiority randomized phase II trial investigating the efficacy and safety of 5FU/LV in combination with regorafenib for patients with metastatic colorectal cancer in the third-line setting. Patients will be randomly assigned in a 2:1 ratio between 5FU/LV combined with regorafenib or trifluridine-tipiracil (FTD-TPI) plus bevacizumab. Arm 1 (Treatment Arm) will consist of the 5FU/LV administered to 38 patients as (LV \[400 mg/m² IV over 120 minutes\], followed by 5FU \[400 mg/m² IV bolus then 2400 mg/m² IV infusion over 46 hours\] in 2-week cycles) and regorafenib will be administered dose of 80-120 mg per day with weekly 40 mg per day increases to a maximum of 120 mg per day for 3 weeks on /1 week off until disease progression, up to 12 cycles of treatment. Arm 2 (Control Arm) received by an additional 19 patients, will be given as FTD-TPI, administered orally, BID, at a starting dose of 35 mg/m2 of body-surface area, on days 1 through 5 and on days 8 through 12 every 28 days. Bevacizumab, at a dose of 5 mg per kilogram of body weight, will be administered intravenously on days 1 and 15. The 28-day treatment cycle continued until disease progression or unacceptable toxic effects occurred or consent was withdrawn, up to 12 cycles of treatment.
CONDITIONS
Official Title
5-Fluorouracil/Leucovorin (5FU/LV) in Combination With Regorafenib in Patients With Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Confirmed diagnosis of metastatic colorectal cancer
- Failed second-line therapy for metastatic disease
- At least one measurable tumor according to RECIST v1.1 criteria
- ECOG performance status between 0 and 2
- Life expectancy of at least 6 months as determined by physician
- Ability to understand and sign informed consent
- Adequate bone marrow, liver, and kidney function based on lab tests including bilirubin, liver enzymes, creatinine, coagulation tests, platelet count, hemoglobin, and neutrophil count
- Negative pregnancy test for women of childbearing potential within 7 days before starting treatment
- Agreement to use effective contraception during the study and for 2 months after last dose
- Ability to swallow and keep oral medication
You will not qualify if you...
- Absolute neutrophil count below 1000 cells/mm3
- Platelet count below 70,000 cells/mm3
- Hemoglobin less than 9 g/dL
- White blood cell count below 3000 cells/mm3
- Liver enzymes (AST or ALT) above 5 times the upper limit of normal if liver metastases present, or above 2.5 times if no liver metastases
- Serum albumin less than 5.8 g/dL
- Total bilirubin above 10 mg/dL
- Prothrombin time or INR above 1.5 times the upper limit of normal, unless within therapeutic limits on anticoagulants
- Serum creatinine or serum urea above 1.5 times the upper limit of normal
- Estimated glomerular filtration rate below 50 mL/min
- Positive pregnancy test, pregnancy, or breastfeeding
- Any significant lab abnormality affecting safety or study outcome
- Uncontrolled or significant heart problems including arrhythmia, bradycardia, tachycardia, symptomatic valvular disease, advanced heart failure, or unstable angina
- Myocardial infarction within 6 months before consent
- Active bleeding disorders
- Persistent or recent constipation, bowel obstruction, or fecaloma within 6 months
- Active or uncontrolled hepatitis B, hepatitis C, or HIV infection
- Recent or active non-colorectal cancers within 3 years except certain low-risk cured cancers
- Recent live attenuated vaccine or close contact with someone who received one within 1 month
- Participation in another investigational study within 30 days
- Active infection above grade 2 severity
- Symptomatic metastatic brain or meningeal tumors
- Non-healing wounds, ulcers, or bone fractures
- Major surgery or significant trauma within 28 days before starting study medication
- Renal failure requiring dialysis
- Previous participation in this study
- Uncontrolled high blood pressure despite treatment
- Recent serious bleeding events
- Recent thrombotic or embolic events within 6 months
- Untreated or concurrent cancers distinct from colorectal cancer, unless cured and disease-free for over 3 years
- Pleural effusion or ascites causing breathing problems
- Known allergy to study drugs or their components
- Any condition making the participant unsuitable for the trial
- Substance abuse or medical, psychological, or social issues interfering with participation
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Trial Site Locations
Total: 1 location
1
Houston Methodist Neal Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Safiya Joseph
CONTACT
T
Titilayo Olubajo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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