Addition of Antibiotics to Upfront Treatment Regimen for Colorectal Cancer

NCT ID: NCT06728072

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-07
• Study Completion Date: 2035-07-01

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).

Detailed Description

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.

Conditions

Colorectal Cancer; CRC

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Standard of Care Chemotherapy + Metronidazole, ciprofloxacin, aspirin

Intervention Type: 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

Interventions

Standard of Care Chemotherapy + Metronidazole, ciprofloxacin, aspirin

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• ongoing full dose anticoagulation Note: Patients on full dose anticoagulation may be approached to discuss study participation if lowering anticoagulation dose is feasible per the discretion of the treating investigator. Patients will be required to lower the anticoagulation dose by half 48 hours before beginning study drugs
• 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
• Antibiotic use in the 30 days before chemotherapy start Note: Use of antibiotics intended for prophylaxis at the time of surgery is allowed
• Corrected QT interval (QTc) >480 on baseline ECG
• Clinically significant hematuria, hematemesis, or hemoptysis of >0.5 teaspoon (2.5 mL) of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 12 weeks before first dose of microbiome modulation therapy (significance determined by treating investigator)
• Diagnosed with a malabsorptive syndrome
• Inability to swallow tablets

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Cancer Society, Inc.

OTHER

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily Kinsey, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Massey IIT Research Operations

Role: CONTACT

masseyepd@vcu.edu

804-628-6430

Facility Contacts

Massey CTO GI Team

Role: primary

masseygi@vcu.edu

804-628-6430

Other Identifiers

HM20031481

Identifier Type: OTHER

Identifier Source: secondary_id

MCC-23-20875

Identifier Type: -

Identifier Source: org_study_id