Antibiotics + Chemotherapy for Colorectal Cancer

Overseen By Massey Investigator-Initiated Trials Research Operations Team

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Virginia Commonwealth University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days

97 Participants Needed

Trial Summary

What is the purpose of 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).

Research Team

Emily Kinsey, MD

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

This trial is for individuals with stage IV colorectal cancer. Participants should be starting their first chemotherapy treatment. The trial excludes those who have had previous treatments for CRC, are allergic to the antibiotics or aspirin being tested, or have other health conditions that could interfere with the study.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard of care chemotherapy with or without MBMT, including metronidazole, ciprofloxacin, and aspirin for 28 days

28 days

Bi-weekly visits for chemotherapy administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, including overall survival and progression-free survival

Up to 5 years

Treatment Details

Interventions

• Aspirin
• Ciprofloxacin
• Metronidazole
• Standard of Care Chemotherapy

Trial Overview The study is testing if adding antibiotics (ciprofloxacin and metronidazole) and aspirin to standard chemotherapy improves outcomes in stage IV colorectal cancer patients. It's a phase 2 trial with two groups: one receiving just chemo, and the other getting chemo plus these additional medications.

Participant Groups

Group I: Metronidazole Ciprofloxacin and Aspirin Therapy Experimental Treatment 1 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 care Active Control 1 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

Standard of Care Chemotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Chemotherapy for:

• Various cancers including breast, lung, colon, pancreatic, and others

Approved in United States as Chemotherapy for:

• Various cancers including breast, lung, colon, pancreatic, and others

Approved in Canada as Chemotherapy for:

• Various cancers including breast, lung, colon, pancreatic, and others

Approved in Japan as Chemotherapy for:

• Various cancers including breast, lung, colon, pancreatic, and others

Approved in China as Chemotherapy for:

• Various cancers including breast, lung, colon, pancreatic, and others

Approved in Switzerland as Chemotherapy for:

• Various cancers including breast, lung, colon, pancreatic, and others

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+