Addition of Antibiotics to Upfront Treatment Regimen for Colorectal Cancer

Phase 2

Waitlist Available

Led By Emily Kinsey, MD

Research Sponsored by Virginia Commonwealth University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Diagnosis of stage IV colorectal cancer

* Measurable disease by Response evaluation criteria in solid tumors (RECIST) 1.1 criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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).

Eligible Conditions

Colorectal Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Best response by analysis using Response Evaluation Criteria in Solid Tumors

Secondary study objectives

Assess the tolerability of the study antibiotic regimen

Assess the tolerability of the study aspirin regimen for the duration of chemotherapy

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.

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Metronidazole Ciprofloxacin and Aspirin TherapyExperimental Treatment1 Intervention

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

Group II: Standard of careActive Control1 Intervention

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

0 / 10Eligibility criteria met