Actively Recruiting
Pilot Study Evaluating Microbiome Modulation Therapy With Ciprofloxacin, Metronidazole, and Aspirin Added to Standard Chemotherapy for Metastatic Colorectal Cancer
Led by Virginia Commonwealth University · Updated on 2026-05-06
97
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
V
Virginia Commonwealth University
Lead Sponsor
A
American Cancer Society, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating treatment outcomes in patients with stage IV colorectal cancer (CRC) by comparing standard first-line chemotherapy alone versus chemotherapy combined with antibiotics and aspirin. This phase 2 pilot study aims to assess the efficacy and safety of adding microbiome modulation therapy (MBMT) with ciprofloxacin, metronidazole, and aspirin to a fluorouracil (5FU)-based chemotherapy regimen for metastatic CRC patients. Participants receive either standard chemotherapy regimens such as FOLFOX, FOLFIRI, or CAPEOX, with or without targeted drugs like bevacizumab or panitumumab, administered every 2 to 3 weeks. The experimental group additionally receives MBMT consisting of 500 mg metronidazole three times daily, 500 mg ciprofloxacin twice daily, and 81 mg aspirin once daily for 28 days. MBMT can start up to 7 days before chemotherapy or within 3 days after chemotherapy begins. During the study, patients undergo evaluations of tumor response using Response Evaluation Criteria in Solid Tumors over up to 5 years. Researchers will also assess overall survival, progression-free survival, and the tolerability and safety of the antibiotic and aspirin regimens. Monitoring includes laboratory tests and safety assessments through day 28 to day 90 depending on treatment arm. The study follows patients for several years to observe treatment effects and outcomes.
CONDITIONS
Brief Title
Addition of Antibiotics to Upfront Treatment Regimen for Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of stage IV colorectal cancer
- Measurable disease by RECIST 1.1 criteria
- Planned first-line treatment with a 5FU-based doublet chemotherapy regimen
- ECOG performance status 0-2
- Absolute neutrophil count 1,500 cells/bcL
- Platelet count 100,000 cells/bcL
- Hemoglobin 8 g/dL (transfusion allowed to reach this level)
- AST and ALT 2.5 times upper limit of normal (ULN), or 5 times ULN if liver metastases present
- Serum creatinine 1.5 times ULN or creatinine clearance 40 mL/min
- Nonpregnant and not breastfeeding
- Use of acceptable contraception if of childbearing potential
- Patients on daily aspirin regimen may continue
- Patients with aspirin contraindications may participate without aspirin
You will not qualify if you...
- Total colectomy
- Diagnosis of Cockayne Syndrome
- Current use of disulfiram, tizanidine, or theophylline that cannot be stopped
- Methotrexate dose of 15 mg/week or more
- History of allergic reaction to ciprofloxacin, metronidazole, or aspirin
- Full course of antibiotics within 30 days before chemotherapy start
- Corrected QT interval (QTc) > 480 on baseline ECG
- Diagnosis of malabsorptive syndrome
- Inability to swallow tablets
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants receive a first-line 5FU-based chemotherapy regimen with or without added microbiome modulation therapy consisting of metronidazole, ciprofloxacin, and aspirin for 28 days.
Visits every 2 to 3 weeks depending on chemotherapy regimen
Duration - Up to 5 years
Participants are monitored for safety and treatment response up to 5 years after treatment.
Periodic visits for assessments over several years
Trial Site Locations
Total: 2 locations
1
Virginia Cancer Institute (VCI)
Richmond, Virginia, United States, 23229
Not Yet Recruiting
2
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
M
Massey IIT Research Operations
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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