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Adding Antibiotics to Chemotherapy for Stage IV Colorectal Cancer

This study is looking at whether adding the antibiotics metronidazole and ciprofloxacin, along with aspirin, to standard chemotherapy helps people with stage IV colorectal cancer (cancer that has spread). You might be able to join if you are 18 or older, have stage IV colorectal cancer that can be measured, and are planning to start a specific type of chemotherapy. The study will measure how well the treatment works by looking at your best response to therapy over up to five years. The current recruitment status is unclear, but the study plans to enroll 97 participants.

Study design
This is a Phase 2 study that compares two groups of participants, one receiving standard chemotherapy and another receiving chemotherapy plus the additional drugs. It is a pilot study to evaluate the effectiveness and safety of these treatments.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants for up to 5 years to measure their best response to treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06728072

Addition of Antibiotics to Upfront Treatment Regimen for Colorectal Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Virginia Commonwealth University
~97 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:Standard of Care Chemotherapy + Metronidazole, ciprofloxacin, aspirin

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Best response by analysis using Response Evaluation Criteria in Solid Tumors
Measured over Up to 5 years

Conditions

Colorectal Cancer
CRC

Explore related trials

Colorectal Carcinoma

Where it's being run

2 sites across 1 states
Virginia2

Study leadership

  • Emily Kinsey, MD · PRINCIPAL_INVESTIGATOR · Virginia Commonwealth University

Who to contact

Massey IIT Research Operations
[email protected]
804-628-6430
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
Absolute neutrophil count (ANC) ≥1,500 cells/μL
Platelet count ≥100,000 cells/μL
Hemoglobin ≥8 g/dL Note: The use of transfusion or other intervention to achieve hemoglobin ≥8 g/dL is acceptable.
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN) Note: Patients with documented liver metastases: AST and ALT ≤5 × ULN
Serum creatinine ≤1.5 x ULN or calculated creatinine clearance ≥40 mL/min using the Cockcroft-Gault equation: (140 - age) × body weight/plasma creatinine × 72 (× 0.85 if female)
Radiographically measurable disease by RECIST 1.1
Nonpregnant and not actively breastfeeding
Sexually active patients of childbearing potential and their partners must agree to use medically acceptable form of contraception, per treating investigator, throughout the study Patients should continue to use medically acceptable methods of contraception after study treatment ends, following the guidance for their specific chemotherapy regimen.
Patients on a pre-existing daily aspirin regimen may participate in the study without interrupting this regimen.
Patients with a contraindication to aspirin may participate in the study. These patients will not be required to take aspirin as part of the study treatment.

Exclusion

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
History of allergic reaction to ciprofloxacin, metronidazole, or aspirin
Fuss course of antibiotics in the 30 days before chemotherapy start Note: Full course is defined as ≥5 doses with an intent to treat a defined infection. Use of antibiotics intended for prophylaxis at the time of surgery is allowed
Corrected QT interval (QTc) \>480 on baseline ECG
Diagnosed with a malabsorptive syndrome
Inability to swallow tablets

What this trial measures

  • Best response by analysis using Response Evaluation Criteria in Solid TumorsUp to 5 years

    Evaluate the objective response rate (ORR) of a fluorouracil (based) treatment regimen with or without the addition of MBMT in patients with colorectal cancer (CRC) by the number of participants that have a partial (PR) or complete response (CR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria.