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
Virginia Commonwealth University
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).
Description
This is a pilot study to evaluate the efficacy and safety of chemotherapy with or without MBMT in patients with metastatic CRC. The primary objective is to evaluate the efficacy, as determined by the ORR, of fluorouracil (5FU) based treatment regimen with and without MBMT in patients with CRC.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 transfu…
Interventions
- DrugStandard of Care Chemotherapy + Metronidazole, ciprofloxacin, aspirin
Metronidazole, ciprofloxacin, aspirin is initiated Cycle 1 Day 1 of chemotherapy. May be initiated any time from 7 days before Cycle 1 Day 1 up to and including Cycle 1 Day 3
Locations (2)
- Virginia Cancer Institute (VCI)Richmond, Virginia
- Virginia Commonwealth UniversityRichmond, Virginia