Addition of Antibiotics to Upfront Treatment Regimen for Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVirginia Commonwealth University
About this trial
This is a 2-arm, noncomparative phase 2 trial designed to evaluate treatment outcomes with or without the addition of ciprofloxacin, metronidazole, and aspirin to first-line chemotherapy for patients with stage IV colorectal cancer (CRC).
Eligibility criteria
Qualifiers
Diagnosis of stage IV colorectal cancer
Measurable disease by Response evaluation criteria in solid tumors (RECIST) 1.1 criteria
Planned first-line treatment with a 5FU-based doublet chemotherapy regimen for colon cancer, specifics of the regimen at the discretion of the treating physician Note: Patients who have received adjuvant therapy >6 months prior are eligible
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
Disqualifiers
Total colectomy
Diagnosed with Cockayne Syndrome
Using disulfiram, tizanidine, or theophylline and unable to stop taking these medications for the length of the microbiome modulation therapy
On methotrexate doses of 15 mg/week or more
Trial design
Treatments tested in this trial
- Standard of Care Chemotherapy + Metronidazole, ciprofloxacin, aspirin
Treatment groups
97 Participants
are divided into 2 treatment groupsSponsors and collaborators
Virginia Commonwealth University
Lead sponsor
American Cancer Society, Inc.
Collaborator
Source ClinicalTrials.gov