Clinical Study Evaluating the Efficacy and Safety of Sulfasalazine in Patients With Metastatic Colorectal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Evaluating the change in the serum level of Ferritin
研究概览
简要总结
The aim of this study is to evaluate the potential efficacy and safety of sulfasalazine in patients with metastatic colorectal cancer.
详细描述
Sulfasalazine is an anti-inflammatory drug that is indicated for treatment of ulcerative colitis and rheumatoid arthritis. Sulfasalazine decreased the risk of ulcerative colitis-related colorectal cancer through its anti-inflammatory effect and induction of oxidative stress in cancer cells. Furthermore, intact sulfasalazine, but not its metabolites, inhibited the growth and metastasis various cancers.
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) colorectal cancer. 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 colorectal cancer
- •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
- •Performance status < 2 according to the Eastern Cooperative Oncology Group (ECOG) score
- •No contraindication to chemotherapy (absence of myelosuppression)
- •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 with concurrent active cancer originating from a primary site other than the colon or rectum
- •Patients who have known allergy to sulfasalazine or its metabolites
- •Patients with nephrolithiasis, severe vomiting or severe diarrhea
- •Patients who are receiving highly plasma protein-bound drugs or drugs with extensive hepatic metabolism such as; coumarin anti-coagulants
- •Patients with intestinal or urinary obstruction
- •Patients with known glucose-6-phosphate dehydrogenase deficiency or porphyria
- •Ongoing treatment with sulfasalazine or mesalamine for ulcerative colitis or rheumatoid arthritis
研究组 & 干预措施
Sulfasalazine Group
This group will include 25 patients who will be scheduled to receive 6 cycles of 5-Fluorouracil and Oxaliplatin- based regimens every 2 weeks plus sulfasalazine (1 gram orally twice daily) for 3 months.
干预措施: Sulfasalazine (Drug)
结局指标
主要结局
Evaluating the change in the serum level of Ferritin
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 Superoxide dismutase (SOD)
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.
Evaluating the change in the serum level of Bcl-2 associated X protein (Bax)
时间窗: 3 months
Blood samples will be collected at baseline and 3 months after treatment.
Investigating the possible efficacy of sulfasalazine through evaluation of its impact on overall response rate (ORR).
时间窗: 3 months
Abdominal, pelvic and chest CT scanning will be performed at baseline and after 3 months. ORR will be evaluated and categorized according to the RECIST 1.1 criteria. ORR includes patients with both complete response and partial response. ORR will be determined as number and percentage.
Investigating the possible efficacy of sulfasalazine through evaluation of its impact on disease control rate (DCR).
时间窗: 3 months
Abdominal, pelvic and chest CT scanning will be performed at baseline and after 3 months. DCR will be evaluated and categorized according to the RECIST 1.1 criteria. DCR includes patients with complete response, partial response and stable disease. DCR will be determined as number and percentage.
次要结局
- Evaluating the progression free survival (PFS)(12 months)
- Evaluating the one-year overall survival (1-year OS)(12 months)
- Evaluating the safety and tolerability of sulfasalazine through investigating Hematological parameters (hemoglobin (mg/dL), erythrocytes (cells/μL), leukocytes (cells/μL), platelets (cells/μL) and absolute neutrophil count (cells/μL)).(3 months)
- Evaluating the safety and tolerability of sulfasalazine through investigating Liver function test.(3 months)
- Evaluating the safety and tolerability of sulfasalazine through investigating Renal function test (serum creatinine (mg/dL), blood urea nitrogen (mg/dL) and creatinine clearance (mL/min)).(3 months)
研究者
Reham Ameen El-Ghoneimy
Assistant Lecturer of Clinical Pharmacy, Faculty of Pharmacy, Tanta University
Tanta University