CTRI/2011/05/001723已完成4 期
A Multi-Centre, Prospective, Open Label Study on the Safety and Efficacy of Irinotecan in Combination Chemotherapy for Metastatic Colorectal Cancer.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Cipla Ltd
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Note: There is no upper age limit
- •1.Subjects or LAR willing to sign an IEC/IRB approved informed consent form before performing any study specific procedures or tests.
- •2.Male and female subjects greater than 18 years of age
- •3.Histologically or cytologically documented adenocarcinoma of the colon or rectum and progressive measurable metastatic disease.
- •4.Subjects in whom a treatment regimen including irinotecan is clinically indicated.
- •5.Subjects who have not received any prior chemotherapy for advanced disease, if adjuvant chemotherapy was administered then should have completed the chemotherapy at least 6 months prior to screening visit.
- •6.Subjects with ?Eastern Cooperative Oncology Group? scale performance status of less than or equal to 2.
- •7.Adequate organ and bone marrow function as evidenced by:
- •a.Hemoglobin greater than or equal to 9.0 g/dL
- •b.Absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L
- •c.Platelet count greater than or equal to 100 x 109/L
- •d.Serum creatinine less than or equal to 1.5 × upper limit of normal (ULN) or creatinine clearance greater than 50 mL/min.
- •e.Aspartate amino transferase (AST) less than or equal to 2.5 x ULN in subjects with no liver metastasis and less than or equal to 5.0 x ULN in subjects with liver metastasis.
- •f.Total bilirubin less than 1.5 x ULN.
- •8.Men and women of childbearing potential who consent to using effective contraception (e.g., hormonal contraceptives, bilateral tubal ligation, barrier with spermicide, intrauterine device) while on treatment and for 3 months thereafter.
- •9.Subjects must be willing and able to comply with scheduled visits and procedures.
- •10.Life expectancy greater than 6 months as per the investigator?s discretion.
排除标准
- •1.No other prior or concurrent malignancy except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix
- •2.Subjects who have a history of presence of brain metastasis, uncontrolled seizure disorder, spinal cord compression, leptomeningeal disease or carcinomatous meningitis.
- •3.Subjects who are planning or in need for a major surgical procedure or radiotherapy (RT) during the study.
- •4.Subjects who have a history of any of the following conditions within 6 months prior to screening:
- •a.Clinically significant myocardial infarction or severe/unstable angina pectoris.
- •b.New York Heart Association (NYHA) class III or IV congestive heart failure.
- •c.Clinically significant cerebrovascular accident, transient ischemic attack or pulmonary embolism.
- •5.Subjects with a risk factor to develop interstitial pulmonary disease.
- •6.Subjects with renal dysfunction and those who are on dialysis
- •7.Subjects who are on treatment with:
- •a.Hormonal therapy, radiation therapy, immunotherapy, biological therapy, and major surgery within 4 weeks before screening.
- •b.Herbal preparations or other alternative medicine within 2 weeks prior to screening visit or during the study.
- •8.Preexisting bleeding diatheses or coagulopathy or the need for full-dose anticoagulation.
- •9.Significant and uncontrolled hepatic dysfunction.
- •10.Co morbid condition that could confound outcome.
- •11.Clinically detectable ascites and pleural effusions.
- •12.Subjects who have a history of active chronic inflammatory bowel disease and/or bowel obstruction within the last 3 months.
- •13.Subjects who are pregnant or breast feeding.
- •14.Known history of hypersensitivity reactions to investigational drug.
- •15.Subjects administered any investigational product within 30 days prior to screening.
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