Addition of Antibiotics to Upfront Treatment Regimen for Colorectal Cancer

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT06728072
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Standard of Care Chemotherapy + Metronidazole, ciprofloxacin, aspirin — DRUG
    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

Study Details

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).

Key Dates

Start date
Mar 7, 2025
Status verified
May 2026
Primary completion
Jul 1, 2035
Completion
Jul 1, 2035

Study Design

Enrollment
97 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Standard of care
    First line chemotherapy as directed. Standard of care chemotherapy treatment options include but are not limited to the following: * FOLFOX every 2 weeks * FOLFIRI every 2 weeks * FOLFOX + bevacizumab or panitumumab every 2 weeks * FOLFIRI + bevacizumab or panitumumab every 2 weeks * CAPEOX every 3 weeks * CAPEOX + bevacizumab or panitumumab every 3 weeks
  • Experimental: Metronidazole Ciprofloxacin and Aspirin Therapy
    First line chemo therapy (standard of care) + Microbiome modulation therapy MBMT 500 mg metronidazole 3 times daily, 500 mg ciprofloxacin twice daily, and 81 mg aspirin once daily for 28 days

Primary Outcome Measure

Best response by analysis using Response Evaluation Criteria in Solid Tumors [ Time Frame: Up to 5 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Virginia Cancer Institute (VCI)RichmondVirginia23229
Sue Moore, MSN, CNS
[email protected]
804-397-9640
Purvi Shah, MD (PRINCIPAL_INVESTIGATOR)
Virginia Commonwealth UniversityRichmondVirginia23298
Massey CTO GI Team
[email protected]
804-628-6430
Emily Kinsey, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Richmond, VA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Virginia Cancer Institute (VCI)· Richmond, VAVirginia Commonwealth University· Richmond, VA

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