RightFit
RecruitingPhase 2

Addition of Antibiotics to Upfront Treatment Regimen for Colorectal Cancer

Pilot Study Evaluating Microbiome Modulation Therapy (MBMT) With Ciprofloxacin, Metronidazole, and Aspirin in Addition to Standard of Care Chemotherapy in Patients Undergoing First-Line Therapy for Metastatic Colorectal Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests first chemotherapy treatment with or without two antibiotics, ciprofloxacin and metronidazole, plus aspirin. It is for people with stage IV colorectal cancer, which is cancer of the colon or rectum that has spread to other parts of the body.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have stage IV colorectal cancer that can be measured on scans.
  • Plan to start a two-drug chemotherapy treatment that includes 5FU. Prior chemotherapy given after surgery is allowed if it ended more than 6 months ago.
  • Be able to care for yourself and be out of bed or a chair for at least half of your waking hours.
  • Have enough blood cells: neutrophils (infection-fighting cells) at least 1,500/μL, platelets (cells that help stop bleeding) at least 100,000/μL, and hemoglobin at least 8 g/dL. Treatment to raise hemoglobin is allowed.
  • Meet liver and kidney blood test limits. Higher liver test levels are allowed if cancer has spread to the liver.
  • Not be pregnant or actively breastfeeding.
  • If you or your partner could become pregnant, agree to use approved birth control during the study and afterward as directed for your chemotherapy.
  • People already taking daily aspirin may continue it. People who cannot safely take aspirin may join without taking it.

Who can't join

  • Have had the whole colon removed.
  • Have Cockayne syndrome, a rare inherited condition.
  • Take disulfiram, tizanidine, or theophylline and cannot stop during the study's antibiotic treatment; or take methotrexate at 15 mg per week or more.
  • Have had an allergic reaction to ciprofloxacin, metronidazole, or aspirin.
  • Took at least 5 antibiotic doses to treat an infection in the 30 days before chemotherapy starts. Antibiotics used to prevent infection during surgery are allowed.
  • Have a QTc above 480 on the first ECG, a test of the heart's electrical activity.
  • Have a condition that keeps your body from absorbing nutrients properly.
  • Cannot swallow tablets.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 * Patients on a pre-existing daily aspirin regimen may participate in the study without interrupting this regimen. * Patients with a contraindication to aspirin may participate in the study. These patients will not be required to take aspirin as part of the study treatment. Exclusion Criteria: * 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

Study sites (2)

VA