Clinical Study Evaluating the Efficacy and Safety of Nitazoxanide in Patients With Metastatic Colorectal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluating the change in the serum level of Superoxide dismutase (SOD)
研究概览
简要总结
The aim of this study is to evaluate the potential efficacy and safety of nitazoxanide in patients with metastatic colorectal cancer.
详细描述
Globally, colorectal cancer (CRC) is a major malignant tumor of the gastrointestinal tract which originates from epithelial cells of the colon and rectum. The efficacy of current cancer therapies is still limited by severe adverse effects on normal tissues and chemoresistance development. Therefore, recent efforts have been focused on the repurposing of existing drugs with good safety profiles for cancer treatment.
Nitazoxanide (NTZ) is considered a broad-spectrum anti-microbial drug with a potent activity against various helminths, anaerobic bacteria and viruses. NTZ inhibited the proliferation of CRC cell lines at or below concentrations that normally exhibit anti-parasitic activity.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of stage IV (metastatic) CRC. Staging will be performed according to the American Joint Committee on Cancer (AJCC) 8th edition and will be documented by all investigating parameters of metastatic CRC
- •Male or female patients with age range from 18-65 years old
- •Women of childbearing age will be required to be on acceptable forms of contraception
- •No contraindication to chemotherapy (absence of myelosuppression)
- •Performance status < 2 according to the Eastern Cooperative Oncology Group (ECOG) score
- •Adequate liver function (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < grade 2) according to the National Cancer Institute-Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v 5.0)
- •Adequate renal function (estimated creatinine clearance (eCrCl), serum creatinine (SCr) < grade 2) according to NCI-CTCAE, v 5.0
- •Adequate hematological parameters (hemoglobin, erythrocytes, platelets, leukocytes and absolute neutrophil count (ANC) < grade 2 according to NCI-CTCAE, v 5.0
排除标准
- •Pregnant or lactating women
- •Patients who have known allergy to nitazoxanide or its metabolites
- •Patients with concurrent active cancer originating from a primary site other than the colon or rectum
- •Patients who are receiving highly plasma protein-bound drugs or drugs with extensive hepatic metabolism such as; coumarin anti-coagulants, oral hypoglycemic drugs and anti-epileptic drugs
研究组 & 干预措施
Nitazoxanide Group
This group will include 30 patients who will be scheduled to receive 6 cycles of 5-Fluorouracil and Oxaliplatin- based regimens every 2 weeks plus nitazoxanide (500 mg orally twice daily) for 3 months.
干预措施: Nitazoxanide (Drug)
结局指标
主要结局
Evaluating the change in the serum level of Superoxide dismutase (SOD)
时间窗: 3 months
Blood samples will be collected at baseline and 3 months after treatment.
Investigating the possible efficacy of nitazoxanide through evaluation of its impact on overall response rate (ORR) and disease control rate (DCR).
时间窗: 3 months
Abdominal, pelvic and chest CT scanning will be performed at baseline and after 3 months. ORR and DCR will be evaluated and categorized according to the RECIST 1.1 criteria. ORR includes patients with both complete response and partial response. DCR includes patients with complete response, partial response and stable disease. Both ORR and DCR will be determined as number and percentage.
Evaluating the change in the serum level of Reduced glutathione (GSH)
时间窗: 3 months
Blood samples will be collected at baseline and 3 months after treatment.
Evaluating the change in the serum level of Protein disulfide isomerase (PDI)
时间窗: 3 months
Blood samples will be collected at baseline and 3 months after treatment.
Evaluating the change in the serum level of Nuclear factor-kappa B (NF-kB)
时间窗: 3 months
Blood samples will be collected at baseline and 3 months after treatment.
次要结局
- Evaluating the safety and tolerability of nitazoxanide through investigating Renal function test (SCr (mg/dL), BUN (mg/dL) and eCrCl (mL/min)).(3 months)
- Evaluating the safety and tolerability of nitazoxanide through investigating Liver function test (ALT (U/mL) and AST (U/mL)).(3 months)
- Evaluating the one-year overall survival (1-year OS)(12 months)
- Evaluating the progression free survival (PFS)(12 months)
- Evaluating the safety and tolerability of nitazoxanide through investigating Hematological parameters (hemoglobin (mg/dL), erythrocytes (cells/μL), leukocytes (cells/μL), platelets (cells/μL) and ANC (cells/μL)).(3 months)
研究者
Reham Ameen El-Ghoneimy
Assistant Lecturer of Clinical Pharmacy, Faculty of Pharmacy, Tanta University
Tanta University