NCT06728072 Addition of Antibiotics to Upfront Treatment Regimen for Colorectal Cancer
| NCT ID | NCT06728072 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Virginia Commonwealth University |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 97 participants |
| Start Date | 2025-03-07 |
| Primary Completion | 2035-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 97 participants in total. It began in 2025-03-07 with a primary completion date of 2035-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Emily Kinsey, MD
PRINCIPAL INVESTIGATOR
Virginia Commonwealth University
Frequently Asked Questions
Who can join the NCT06728072 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06728072 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06728072 currently recruiting?
Yes, NCT06728072 is actively recruiting participants. Contact the research team at masseyepd@vcu.edu for enrollment information.
Where is the NCT06728072 trial being conducted?
This trial is being conducted at Richmond, United States, Richmond, United States.
Who is sponsoring the NCT06728072 clinical trial?
NCT06728072 is sponsored by Virginia Commonwealth University. The principal investigator is Emily Kinsey, MD at Virginia Commonwealth University. The trial plans to enroll 97 participants.
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