Actively Recruiting
Trial of 5-Fluorouracil (5FU)-Based Therapy in Combination With Fruquintinib in Patients With Locally Advanced Unresectable or Metastatic Colorectal Cancer
Led by The Methodist Hospital Research Institute · Updated on 2026-04-09
50
Participants Needed
1
Research Sites
200 weeks
Total Duration
On this page
Sponsors
T
The Methodist Hospital Research Institute
Lead Sponsor
T
Takeda Development Center Americas, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This Phase II clinical trial at Houston Methodist Neal Cancer Center is evaluating the safety and efficacy of combining 5-Fluorouracil (5FU) -based chemotherapy (either FOLFIRI: folinic acid, 5FU, irinotecan; or mFOLFOX6: folinic acid, 5FU, oxaliplatin) with fruquintinib as a first-line treatment for patients with locally advanced unresectable or metastatic colorectal cancer. Fifty patients will receive treatment in 28-day cycles, with fruquintinib initially dosed at 4 mg daily and potentially increased to 5 mg if no significant toxicities are observed. After six months, patients showing stable disease or better will transition to a maintenance phase with 5FU and fruquintinib, continuing until disease progression or other discontinuation criteria are met. The primary endpoint is time to progression based on RECIST v1.1 criteria, while secondary endpoints include safety, tolerability, and duration of response. The trial is being conducted across multiple Houston Methodist hospitals and is currently the only first-line CRC trial available in the system. If successful, it could offer a new therapeutic option and inform future treatment guidelines for advanced colorectal cancer.
CONDITIONS
Official Title
Trial of 5-Fluorouracil (5FU)-Based Therapy in Combination With Fruquintinib in Patients With Locally Advanced Unresectable or Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years of age or older
- Signed informed consent before any study procedures
- Confirmed locally advanced unresectable or metastatic colorectal cancer
- Measurable disease based on RECIST v1.1 criteria
- No prior systemic treatment for colorectal cancer
- ECOG performance status of 0 or 1
- Life expectancy of at least 6 months as assessed by treating physician
- Use of effective contraception during study and for 30 days after last treatment dose if of childbearing potential
- Ability to swallow oral tablets
You will not qualify if you...
- Absolute neutrophil count less than 1500 cells/mm3
- Platelet count less than 100,000 cells/mm3
- Hemoglobin less than 9 g/dL
- White blood count less than 3000 cells/mm3
- Elevated liver enzymes: AST or ALT greater than 5 times the upper limit of normal with liver metastases or greater than 2.5 times without
- Serum albumin less than 2.8 g/dL
- Total bilirubin greater than 1.7 mg/dL times upper limit of normal
- Prothrombin time or INR greater than 1.5 times upper limit (therapeutic anticoagulation may be allowed within limits)
- Serum creatinine or urea greater than 1.5 times upper limit of normal
- Glomerular filtration rate less than 50 mL/min
- Proteinuria of 2+ or more by dipstick or 1.0 g/24-hour urine protein
- Positive pregnancy test, pregnant, or breastfeeding if female of childbearing potential
- Significant or uncontrolled cardiac conditions including arrhythmia, bradycardia, tachycardia, symptomatic valvular disease, advanced heart failure (NYHA Class III or IV), unstable angina
- Myocardial infarction within 6 months prior to consent
- Active bleeding disorders
- Persistent or chronic constipation or bowel obstruction within last 6 months
- Chronic corticosteroid treatment over 5 mg prednisone daily or equivalent (topical/nasal allowed)
- Known or uncontrolled hepatitis B, hepatitis C, or HIV infection
- History of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- History or active treatment of other malignancies within 5 years except certain skin and in situ cancers
- Recent live attenuated vaccine within 1 month prior to consent
- Investigational agent use within 30 days prior to consent for conditions other than colorectal cancer
- Protein or antibody therapy within 3 months prior to consent for non-colorectal cancer conditions
- Uncontrolled hypertension
- Active infection requiring treatment
- Recent major surgery
- Thromboembolic events within past 6 months
- Unable to provide informed consent
- Prisoner status
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here