Addition of Antibiotics to Upfront Treatment Regimen for Colorectal Cancer

Launched by VIRGINIA COMMONWEALTH UNIVERSITY · Dec 5, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how adding antibiotics (ciprofloxacin and metronidazole) and aspirin to standard chemotherapy might affect treatment outcomes for patients with stage IV colorectal cancer (CRC). The trial aims to find out if this combination can improve the effectiveness of first-line chemotherapy, which is the initial treatment given to patients. It is currently recruiting participants aged between 65 and 74, and anyone can join regardless of gender, as long as they meet the eligibility criteria.

To be eligible for this trial, you must have a confirmed diagnosis of stage IV colorectal cancer and be planning to start a chemotherapy regimen that includes 5FU, a common chemotherapy drug. Other requirements include having a specific level of health (measured by performance status) and certain blood counts. Participants can expect to receive either the standard chemotherapy or the chemotherapy with the added antibiotics and aspirin. It’s important to note that patients who have had recent antibiotic use or certain medical conditions may not be able to participate. If you or someone you know is interested, it’s a good idea to discuss this with a healthcare provider who can provide more information about the trial and whether it's a suitable option.

Gender

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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