Actively Recruiting
Addition of Antibiotics to Upfront Treatment Regimen for Colorectal Cancer
Led by Virginia Commonwealth University · Updated on 2026-05-06
97
Participants Needed
2
Research Sites
538 weeks
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
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).
CONDITIONS
Official 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 Response evaluation criteria in solid tumors (RECIST) 1.1 criteria
- Planned first-line treatment with a 5FU-based doublet chemotherapy regimen for colon cancer
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Absolute neutrophil count at least 1,500 cells/µL
- Platelet count at least 100,000 cells/µL
- Hemoglobin at least 8 g/dL (transfusion or intervention allowed to achieve this)
- AST and ALT up to 2.5 times upper limit of normal (ULN), or up to 5 times ULN if liver metastases are documented
- Serum creatinine up to 1.5 times ULN or creatinine clearance at least 40 mL/min
- Nonpregnant and not actively breastfeeding
- Agree to use medically acceptable contraception if sexually active and of childbearing potential
- Patients on daily aspirin can participate without stopping
- Patients with aspirin contraindication can participate without taking aspirin
You will not qualify if you...
- Total colectomy
- Diagnosis of Cockayne Syndrome
- Use of disulfiram, tizanidine, or theophylline without ability to stop during microbiome modulation therapy
- Methotrexate dose 15 mg/week or higher
- History of allergic reaction to ciprofloxacin, metronidazole, or aspirin
- Full course of antibiotics (5 or more doses) in 30 days before starting chemotherapy (prophylactic antibiotics for surgery allowed)
- Corrected QT interval (QTc) over 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
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
CONTACT
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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