Study on 5-Fluorouracil (5FU) and Fruquintinib for Advanced Colorectal Cancer

Sponsor: The Methodist Hospital Research Institute

Sponsor score: 0

ClinicalTrials ID:NCT07042685

Provider View

This clinical trial is testing a combination of chemotherapy and a new drug, fruquintinib, to see if it can help treat advanced colorectal cancer that cannot be removed by surgery or has spread to other parts of the body.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of combining 5-Fluorouracil (5FU)-based chemotherapy with fruquintinib for patients with advanced colorectal cancer. The trial involves 50 patients who will receive treatment in 28-day cycles. Fruquintinib will start at a dose of 4 mg daily and may be increased to 5 mg if no significant side effects occur. After six months, patients with stable or improved disease will continue with a maintenance phase using 5FU and fruquintinib until the cancer progresses or other conditions for stopping treatment are met.

Description

This study is testing a new treatment for advanced colorectal cancer that combines a standard chemotherapy drug, 5-Fluorouracil (5FU), with a new drug called fruquintinib. The trial is being conducted at Houston Methodist Neal Cancer Center and involves 50 patients. Participants will receive either FOLFIRI or mFOLFOX6 chemotherapy regimens along with fruquintinib. The treatment is given in 28-day cycles, and the dose of fruquintinib may be increased if no major side effects are observed. After six months, patients who show stable or improved disease will continue with a maintenance treatment of 5FU and fruquintinib. The study aims to determine how long it takes for the cancer to progress and to assess the safety and tolerability of the treatment. The trial is being conducted across multiple Houston Methodist hospitals and is the only first-line colorectal cancer trial available in the system. If successful, it could provide a new treatment option for advanced colorectal cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must provide written informed consent before any trial-specific tests or procedures.
  • Must have a confirmed diagnosis of advanced colorectal cancer that cannot be removed by surgery or has spread.
  • Must have measurable disease according to specific criteria.
  • Must not have received prior systemic treatment for colorectal cancer.
  • Must have a performance status indicating they are fully active or restricted in physically strenuous activity but ambulatory.
  • Must have a life expectancy of at least 6 months.
  • Women of childbearing potential must agree to use effective contraception during the study and for 30 days after the last dose.
  • Must be able to swallow oral tablets.

Exclusion Criteria

  • Low blood cell counts or abnormal liver function tests.
  • Low levels of serum albumin or high levels of bilirubin.
  • Abnormal blood clotting times unless on stable anticoagulation therapy.
  • Poor kidney function or high levels of protein in urine.
  • Positive pregnancy test, pregnant, or breastfeeding.
  • Any other significant lab abnormalities that could affect safety or study outcomes.
  • Significant heart problems or recent heart attack.
  • Active bleeding disorders or severe constipation.
  • Use of certain medications like high-dose steroids or immunosuppressive agents.
  • History of certain infections or other cancers within the last 5 years.
  • Recent vaccination with live vaccines or participation in other clinical trials.
  • Uncontrolled high blood pressure or active infections.
  • Recent major surgery or blood clots.
  • Inability to consent or being a prisoner.

Locations

FACILITYZIPCITYSTATE
Houston Methodist Neal Cancer Center77030HoustonTexas

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