Adding antibiotics to chemotherapy for colorectal cancer treatment
Pilot Study Evaluating Microbiome Modulation Therapy (MBMT) With Ciprofloxacin, Metronidazole, and Aspirin in Addition to Standard of Care Chemotherapy in Patients Undergoing First-Line Therapy for Metastatic Colorectal Cancer
PHASE2 · Virginia Commonwealth University · NCT06728072
This study is testing if adding antibiotics and aspirin to standard chemotherapy can help people with stage IV colorectal cancer respond better to their first treatment.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 97 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Virginia Commonwealth University (other) |
| Drugs / interventions | chemotherapy, methotrexate |
| Locations | 2 sites (Richmond, Virginia and 1 other locations) |
| Trial ID | NCT06728072 on ClinicalTrials.gov |
What this trial studies
This phase 2 trial evaluates the effectiveness and safety of adding ciprofloxacin, metronidazole, and aspirin to standard chemotherapy in patients with stage IV colorectal cancer. It is a noncomparative study that aims to determine the overall response rate of this combined treatment approach. Patients will receive either the standard chemotherapy regimen or the regimen with the added antibiotics and aspirin. The study focuses on patients who are starting their first-line treatment for metastatic colorectal cancer.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with stage IV colorectal cancer who are eligible for first-line chemotherapy.
Not a fit: Patients who have previously received chemotherapy for their colorectal cancer within the last six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with stage IV colorectal cancer.
How similar studies have performed: Other studies have explored the addition of antibiotics to cancer treatment, but this specific combination and approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Childbearing potential excludes: Age \> 50 years and naturally amenorrhoeic for \> 1 year OR previous hysterectomy or bilateral salpingo-oophorectomy * 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 Criteria: * 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
Where this trial is running
Richmond, Virginia and 1 other locations
- Virginia Cancer Institute (VCI) — Richmond, Virginia, United States (NOT_YET_RECRUITING)
- Virginia Commonwealth University — Richmond, Virginia, United States (RECRUITING)
Study contacts
- Principal investigator: Emily Kinsey, MD — Virginia Commonwealth University
- Study coordinator: Massey IIT Research Operations
- Email: masseyepd@vcu.edu
- Phone: 804-628-6430
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colorectal Cancer, CRC