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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 97
- 试验地点
- 3
- 主要终点
- Best response by analysis using Response Evaluation Criteria in Solid Tumors
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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
干预措施: Standard of Care Chemotherapy + Metronidazole, ciprofloxacin, aspirin (Drug)
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
结局指标
主要结局
Best response by analysis using Response Evaluation Criteria in Solid Tumors
时间窗: Up to 5 years
Evaluate the objective response rate (ORR) of a fluorouracil (based) treatment regimen with or without the addition of MBMT in patients with colorectal cancer (CRC) by the number of participants that have a partial (PR) or complete response (CR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria.
次要结局
- Estimate the overall survival (OS) of patients with colorectal cancer (CRC) treated with a 5FU-based treatment regimen with or without the addition of MBMT.(Up to 5 years)
- Estimate the progression free survival (PFS) of patients with CRC treated with a 5FU-based treatment regimen with or without the addition of the MBMT(Up to 5 years)
- Assess the tolerability of the study antibiotic regimen(Day 28 +/- 7 days)
- Assess the tolerability of the study aspirin regimen for the duration of chemotherapy(Day 28 +/- 7 days)
- Evaluate the safety of MBMT in addition to a 5FU-based treatment regimen(Beginning of study procedures through day 28 Non-interventional arm), through day 90 (interventional arm))