Study on Adding Antibiotics to Initial Treatment for Advanced Colorectal Cancer

Sponsor: Virginia Commonwealth University

Sponsor score: 0

ClinicalTrials ID:NCT06728072

Provider View

This clinical trial is exploring whether adding antibiotics and aspirin to the first round of chemotherapy can improve treatment outcomes for patients with stage IV colorectal cancer.

Patient Parameters

Program Overview

The study aims to find out if using antibiotics (ciprofloxacin and metronidazole) and aspirin along with the standard chemotherapy can help treat stage IV colorectal cancer more effectively. The trial will compare the results of patients receiving just chemotherapy with those receiving the additional medications.

Description

This trial is testing a new approach to treating advanced colorectal cancer by adding antibiotics and aspirin to the usual chemotherapy. The main goal is to see if this combination can improve how well the cancer responds to treatment. The study will look at how effective the treatment is by measuring the response rate of the cancer to the chemotherapy with and without the added medications. Participants will receive a chemotherapy regimen based on fluorouracil (5FU), and the study will monitor the safety and effectiveness of this approach.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with stage IV colorectal cancer.
  • Have cancer that can be measured using standard criteria.
  • Plan to start first-line treatment with a specific type of chemotherapy for colon cancer.
  • Have a performance status score of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate blood cell counts and organ function, including:
    • Neutrophil count of at least 1,500 cells/μL.
    • Platelet count of at least 100,000 cells/μL.
    • Hemoglobin level of at least 8 g/dL (transfusions allowed to meet this level).
    • Liver enzymes within specified limits, with higher limits for those with liver metastases.
    • Kidney function within specified limits.
  • Have cancer that can be measured by scans.
  • Not pregnant or breastfeeding.
  • Agree to use effective contraception during and after the study if of childbearing potential.

Exclusion Criteria

  • Currently on full-dose blood thinners, unless the dose can be safely reduced.
  • Have had a total removal of the colon.
  • Diagnosed with Cockayne Syndrome.
  • Taking certain medications (disulfiram, tizanidine, theophylline) that cannot be stopped during the study.
  • Taking high doses of methotrexate (15 mg/week or more).
  • Allergic to ciprofloxacin, metronidazole, or aspirin.
  • Used antibiotics in the 30 days before starting chemotherapy.
  • Have a prolonged QT interval on an ECG.
  • Have significant bleeding issues or history of bleeding within 12 weeks before starting the study.
  • Diagnosed with a condition that affects nutrient absorption.
  • Unable to swallow tablets.

Locations

FACILITYZIPCITYSTATE
Virginia Commonwealth University23298RichmondVirginia

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