Regorafenib with a fluoropyrimidine for metastatic colorectal cancer after progression on multiple 5-FU-containing combination therapies and regorafenib monotherapy.
Eric I Marks, Carlyn Tan, Jun Zhang...
https://pubmed.ncbi.nlm.nih.gov/26561209Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID06887218
Randomized Phase II Trial of 5-Fluorouracil/Leucovorin Combined With Regorafenib Versus Trifluridine-Tipiracil Plus Bevacizumab in Patients With Metastatic Colorectal Cancer
Led by The Methodist Hospital Research Institute · Updated on 2025-08-27
57
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating treatments for patients with metastatic colorectal cancer who have not responded to second-line therapy. This randomized phase II trial compares the combination of 5-fluorouracil/leucovorin (5FU/LV) with regorafenib against a combination of trifluridine-tipiracil (FTD-TPI) plus bevacizumab. The study aims to evaluate the effectiveness and safety of these treatments in this third-line setting. Participants are randomly assigned in a 2:1 ratio to one of two groups. The first group receives 5FU/LV given intravenously in two-week cycles along with regorafenib taken orally daily with dose escalation over three weeks followed by one week off, continuing up to 12 cycles or until disease progression. The second group receives FTD-TPI orally twice daily on specific days of a 28-day cycle and bevacizumab intravenously on days 1 and 15, also continuing up to 12 cycles or until disease progression or unacceptable side effects. During the study, participants will undergo regular assessments to monitor treatment effects and safety. Researchers will track the time from treatment start until disease progression, unacceptable toxicity, or withdrawal, assessing up to 18 months. Safety and tolerability will also be evaluated. The trial includes laboratory tests and clinical evaluations throughout the treatment period, with the possibility to withdraw at any time. Total participation duration depends on individual treatment response and tolerance.
CONDITIONS
Brief Title
5-Fluorouracil/Leucovorin (5FU/LV) in Combination With Regorafenib in Patients With Metastatic Colorectal Cancer
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Histopathologically or cytologically confirmed metastatic colorectal cancer
- Failed second-line therapy for metastatic disease
- At least one measurable tumor per RECIST v1.1 criteria
- ECOG performance status between 0 and 2
- Life expectancy of 6 months or more as judged by a physician
- Ability to understand and sign informed consent
- Adequate bone marrow, liver, and kidney function based on specified laboratory values
- Negative pregnancy test for women of childbearing potential within 7 days before starting treatment
- Agreement to use adequate contraception during and for 2 months after treatment
- Ability to swallow and retain oral medication
You will not qualify if you...
- Absolute neutrophil count less than 1000 cells/mm3
- Platelet count less than 70,000 cells/mm3
- Hemoglobin less than 9 g/dL
- White blood count less than 3000 cells/mm3
- Liver enzymes above specified limits depending on liver metastases
- Serum albumin less than 5.8 g/dL
- Total bilirubin greater than 10 mg/dL
- Prothrombin time or INR greater than 1.5 times normal
- Serum creatinine or urea above 1.5 times normal
- Estimated glomerular filtration rate below 50 mL/min
- Positive pregnancy test, pregnant or breastfeeding women
- Significant uncontrolled heart conditions or recent heart attack
- Active bleeding disorders or recent severe bleeding events
- Persistent constipation, bowel obstruction, or fecaloma within 6 months
- Active or uncontrolled hepatitis B, hepatitis C, or HIV infection
- Recent non-colorectal cancers within 3 years except low-risk cured cancers
- Recent live attenuated vaccine or contact with vaccinated individuals within 1 month
- Participation in other investigational treatments within past 30 days
- Symptomatic brain or meningeal tumors
- Non-healing wounds, ulcers, or bone fractures
- Recent major surgery or trauma within 28 days
- Renal failure requiring dialysis
- Previous participation in this study
- Uncontrolled hypertension despite treatment
- Recent thrombotic or embolic events within 6 months
- Other untreated or concurrent cancers except specified exceptions
- Pleural effusion or ascites causing breathing problems
- Known allergies to study drugs or their components
- Any condition or substance abuse affecting safe participation or study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 12 cycles of treatment
Participants receive one of two drug regimens: 5FU/LV combined with regorafenib or trifluridine-tipiracil plus bevacizumab. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or up to 12 cycles.
Treatment cycles every 2 or 4 weeks depending on regimen with dosing on specified days
Trial Site Locations
Total: 1 location
1
Houston Methodist Neal Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
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Research Team
S
Safiya Joseph
T
Titilayo Olubajo
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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https://pubmed.ncbi.nlm.nih.gov/24714698Case report: Efficacy and safety of regorafenib plus fluorouracil combination therapy in the treatment of refractory metastatic colorectal cancer.
Emaan Haque, Ibrahim N Muhsen, Abdullah Esmail...
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https://pubmed.ncbi.nlm.nih.gov/1588370FOLFOX/FOLFIRI pharmacogenetics: the call for a personalized approach in colorectal cancer therapy.
Beatrice Mohelnikova-Duchonova, Bohuslav Melichar, Pavel Soucek
https://pubmed.ncbi.nlm.nih.gov/25132748Regorafenib dose-optimisation in patients with refractory metastatic colorectal cancer (ReDOS): a randomised, multicentre, open-label, phase 2 study.
Tanios S Bekaii-Saab, Fang-Shu Ou, Daniel H Ahn...
https://pubmed.ncbi.nlm.nih.gov/31262657