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New treatment option for Colorectal Cancer
Official title Addition of Antibiotics to Upfront Treatment Regimen for Colorectal Cancer
ClinicalTrials.gov ID: NCT06728072
What this study is testing
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- Absolute neutrophil count (ANC) ≥1,500 cells/μL
You likely can't join 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...
See the full eligibility 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...
- 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...
- 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.
- 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...
- Corrected QT interval (QTc) \>480 on baseline ECG
- Diagnosed with a malabsorptive syndrome
- Inability to swallow tablets
The study team makes the final eligibility decision.
Where it's taking place
- Richmond, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Richmond, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.