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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
97
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
Virginia Cancer Institute (VCI)
Richmond, Virginia, United States
RECRUITINGVirginia Commonwealth University
Richmond, Virginia, United States
RECRUITINGBest 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
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.
Evaluate the overall participant survival (OS) defined as the duration of time from diagnosis to date of death by any cause.
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
Progression free survival (PFS) is defined as the duration of time from start of study 5FU-based treatment regimen to date of first progression or relapse.
Time frame: Up to 5 years
Assess the tolerability of the study antibiotic regimen
Total number of antibiotic doses over 28 days
Time frame: Day 28 +/- 7 days
Assess the tolerability of the study aspirin regimen for the duration of chemotherapy
Total number of aspirin doses over 28 days
Time frame: Day 28 +/- 7 days
Evaluate the safety of MBMT in addition to a 5FU-based treatment regimen
The number of Adverse Events (AEs) captured using criteria in the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
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Time frame: Beginning of study procedures through day 28 Non-interventional arm), through day 90 (interventional arm)