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New treatment option for Metastatic Colorectal Cancer (CRC)
Official title Trial of 5-Fluorouracil (5FU)-Based Therapy in Combination With Fruquintinib in Patients With Locally Advanced Unresectable or Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT07042685
What this study is testing
What is Fruquintinib Combined With Chemotherapy?
Fruquintinib Combined With Chemotherapy is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for metastatic colorectal cancer (crc).
Also referred to as Fruquintinib.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female ≥18 years of age.
- Written informed consent is required before performing any trial-specific tests or procedures. Signing of the informed consent form can occur outside...
- Histopathologically or cytologically confirmed locally advanced unresectable or metastatic colorectal cancer. The study will include an all-comer...
- Measurable disease per RECISTv1.1.
- No prior systemic treatment. Patients with resected disease who later develop unresectable recurrence without prior systemic therapy remain eligible.
You likely can't join if
- Hematology laboratory values of:
- Absolute neutrophil count ≤1500 cells/mm3
- Platelets ≤100,000 cells/mm3
- Hemoglobin ≤9 g/dL
- White blood count ≤3000 cells/mm3.
- Hepatic laboratory values of aspartate transaminase (AST) or alanine aminotransferase (ALT):
See the full eligibility criteria
- Male or female ≥18 years of age.
- Written informed consent is required before performing any trial-specific tests or procedures. Signing of the informed consent form can occur outside the 28-day screening period.
- Histopathologically or cytologically confirmed locally advanced unresectable or metastatic colorectal cancer. The study will include an all-comer population, meaning that patients will not be excluded based on specific...
- Measurable disease per RECISTv1.1.
- No prior systemic treatment. Patients with resected disease who later develop unresectable recurrence without prior systemic therapy remain eligible.
- ECOG performance status of 0 or 1.
- Life expectancy ≥6 months per treating physician's assessment.
- Patients of childbearing potential must agree to use an adequate method of contraception during the study and for 30 days after the last dose of study treatment.
- Patients must be able to swallow oral tablets.
- Hematology laboratory values of:
- Absolute neutrophil count ≤1500 cells/mm3
- Platelets ≤100,000 cells/mm3
- Hemoglobin ≤9 g/dL
- White blood count ≤3000 cells/mm3.
- Hepatic laboratory values of aspartate transaminase (AST) or alanine aminotransferase (ALT):
- \>5 × upper limits of normal (ULN) if the documented history of hepatic metastases; or
- \>2.5 × ULN if no liver metastases are present.
- Serum albumin \<2.8 g/dL.
- Total bilirubin \>1.7 mg/dL × ULN.
- Prothrombin time (PT) or international normalized ratio (INR) \>1.5 × ULN. Note: Patients receiving therapeutic doses of anticoagulant therapy may be considered eligible if PT and INR are within the acceptable...
- Serum creatinine or serum urea \>1.5 × ULN.
- Estimated glomerular filtration rate \<50 mL/min.
- Urine dipstick or urinalysis with protein ≥2+ or 24-hour urine protein ≥1.0 g/24-h. people with 1+ proteinuria must undergo a 24-hour urine collection to assess urine protein level.
- Positive pregnancy test, pregnant, or breastfeeding for all women of child-bearing potential.
- Per treating physician's assessment, any other clinically significant laboratory abnormality that would compromise patient safety or the outcome of the study.
- Any clinically significant and/or uncontrolled cardiac-related abnormality that would compromise patient safety or the outcome of the study including, but not limited to:
- Arrhythmia
- Bradycardia
- Tachycardia
- Symptomatic valvular disease
- Symptomatic congestive heart failure is classified by the New York Heart Association as Class III or IV
- Unstable angina pectoris.
- Myocardial infarction within the past 6 months from consent.
- Active bleeding diathesis.
- Current complaints of persistent constipation or history of chronic constipation, untreatable bowel obstruction, or fecaloma within the past 6 months from consent.
- Receiving chronic treatment with corticosteroids ≥5 mg of prednisone per day (or equivalent) or other systemic immunosuppressive agents. Topical or nasal corticosteroids are allowed.
- Known history and/or uncontrolled hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV)-1 or HIV-2.
- History of galactose intolerance, deficiency of Lapp lactase, or glucose-galactose malabsorption.
- History of malignancy or active treatment for malignancy other than CRC (i.e., radiation or chemotherapy, including monoclonal antibodies) within 5 years. Note: Patients with squamous or basal cell carcinomas of the...
- Receipt of live, attenuated vaccine (e.g., intranasal influenza, measles, mumps, rubella, varicella) or close contact with someone who has received a live, attenuated vaccine within the past 1 month from consent. Note...
- Receipt of any investigational agent or study treatment within the past 30 days from consent for a condition other than CRC.
- Receipt of any protein or antibody-based therapeutic agents (e.g., growth hormones or monoclonal antibodies) within the past 3 months from consent for a condition other than CRC.
- Uncontrolled hypertension
- Active infection requiring treatment
- Recent history of major surgery
- Thromboembolic events during the past 6 months
- Adults unable to consent
- Prisoners
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.