Addition of Antibiotics to Upfront Treatment Regimen for Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVirginia Commonwealth University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Standard of Care Chemotherapy + Metronidazole, ciprofloxacin, aspirin
DrugMetronidazole, 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
Treatment groups
97 Participants
are divided into 2 treatment groupsGroup A: Standard of careNo intervention 0 interventions
Group B: Metronidazole Ciprofloxacin and Aspirin TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 yearsSecondary outcomes
1
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 years2
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 years3
Assess the tolerability of the study antibiotic regimen
Total number of antibiotic doses over 28 days
Time frame
Day 28 +/- 7 days4
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 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Virginia Commonwealth University
Lead sponsor
American Cancer Society, Inc.
Collaborator
Source ClinicalTrials.gov