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
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).
Detailed 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.
Arms & 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
Outcome measures
Primary
Best response by analysis using Response Evaluation Criteria in Solid Tumors
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.
Time frame: Up to 5 years
Secondary
Estimate the overall survival (OS) of patients with colorectal cancer (CRC) treated with a 5FU-based treatment regimen with or without the addition of MBMT.
Time frame: Up to 5 years
Estimate the progression free survival (PFS) of patients with CRC treated with a 5FU-based treatment regimen with or without the addition of the MBMT
Time frame: Up to 5 years
Assess the tolerability of the study antibiotic regimen
Time frame: Day 28 +/- 7 days
Assess the tolerability of the study aspirin regimen for the duration of chemotherapy
Time frame: Day 28 +/- 7 days
Evaluate the safety of MBMT in addition to a 5FU-based treatment regimen
Time frame: Beginning of study procedures through day 28 Non-interventional arm), through day 90 (interventional arm)
Eligibility criteria
Study locations (2)
Virginia Cancer Institute (VCI)
Richmond, Virginia, 23229
Virginia Commonwealth University
Richmond, Virginia, 23298