Addition of Antibiotics to Upfront Treatment Regimen for Colorectal Cancer

NCT06728072 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: MCC-23-20875HM20031481
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Colorectal Cancer; CRC

Keywords

Colorectal Cancer; CRC

Outcome Measures

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.

  Up to 5 years

Secondary Outcomes (5)

• 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.

  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

  Up to 5 years

• Assess the tolerability of the study antibiotic regimen

  Day 28 +/- 7 days

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

  Day 28 +/- 7 days

• Evaluate the safety of MBMT in addition to a 5FU-based treatment regimen

  Beginning of study procedures through day 28 Non-interventional arm), through day 90 (interventional arm)

Study Arms (2)

Standard of care

NO 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

Metronidazole Ciprofloxacin and Aspirin Therapy

EXPERIMENTAL

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

Drug: Standard of Care Chemotherapy + Metronidazole, ciprofloxacin, aspirin

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

Metronidazole Ciprofloxacin and Aspirin Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Absolute neutrophil count (ANC) ≥1,500 cells/μL
• Platelet count ≥100,000 cells/μL
• Hemoglobin ≥8 g/dL Note: The use of transfusion or other intervention to achieve hemoglobin ≥8 g/dL is acceptable.
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN) Note: Patients with documented liver metastases: AST and ALT ≤5 × ULN
• Serum creatinine ≤1.5 x ULN or calculated creatinine clearance ≥40 mL/min using the Cockcroft-Gault equation: (140 - age) × body weight/plasma creatinine × 72 (× 0.85 if female)
• Radiographically measurable disease by RECIST 1.1
• Nonpregnant and not actively breastfeeding
• Sexually active patients of childbearing potential and their partners must agree to use medically acceptable form of contraception, per treating investigator, throughout the study Patients should continue to use medically acceptable methods of contraception after study treatment ends, following the guidance for their specific chemotherapy regimen.
• Childbearing potential excludes:
• Age \> 50 years and naturally amenorrhoeic for \> 1 year OR previous hysterectomy or bilateral salpingo-oophorectomy
• Patients on a pre-existing daily aspirin regimen may participate in the study without interrupting this regimen.

You may not qualify if:

• 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
• History of allergic reaction to ciprofloxacin, metronidazole, or aspirin
• Fuss course of antibiotics in the 30 days before chemotherapy start Note: Full course is defined as ≥5 doses with an intent to treat a defined infection. Use of antibiotics intended for prophylaxis at the time of surgery is allowed
• Corrected QT interval (QTc) \>480 on baseline ECG
• Diagnosed with a malabsorptive syndrome
• Inability to swallow tablets

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• American Cancer Society, Inc.: collaborator

Study Sites (2)

Virginia Cancer Institute (VCI)

Richmond, Virginia, 23229, United States

NOT YET RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Metronidazole; Ciprofloxacin; Aspirin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Emily Kinsey, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Massey IIT Research Operations

CONTACT

804-628-6430; masseyepd@vcu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: December 11, 2024
• Study Start: March 7, 2025
• Primary Completion (Estimated): July 1, 2035
• Study Completion (Estimated): July 1, 2035
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)