CTRI/2011/05/001722已完成4 期
A Multi-Center, Prospective, Open Label Study on the Safety and Efficacy of Gemcitabine with Cisplatin in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) - NI
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
- •1.Subject/LAR willing to sign an IEC/IRB approved ICF before performing any study specific procedures or tests.
- •2.Male and female subjects aged between 18 to 75 years.
- •3.Subjects with histologically or cytologically confirmed diagnosis of stage IIIB/IV NSCLC in squamous or undetermined cells.
- •4.Subject who had at least one bi-dimensionally measurable lesion.
- •5.Subjects who have not had prior chemotherapy.
- •6.At least 4 weeks should have elapsed since subjects received any radiation therapy(previous radiotherapy, either in the adjuvant setting or for the treatment of metastatic disease is allowed provided that the measurable lesions are outside the radiation fields).
- •7.Subjects with an ?Eastern Cooperative Oncology Group? scale performance status less than or equal to 2.
- •8.Subjects with a screening hematology and blood biochemistry values of:
- •a.WBC greater than 4,000/mL
- •b.ANC greater than 1,500/mL
- •c.Platelets greater than 100,000/mL
- •d.Hb greater than or equal to 9g/dL
- •e.ALT/AST less than or equal to 5 times x UNL
- •f.Bilirubin less than or equal to 1.5times x UNL
- •g.Creatinine less than or equal to 1.25 times x UNL
- •h.Calcium level within the normal range (9-11mg/dL)
- •9.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.
- •10.Subjects must be willing and must be able to comply with scheduled visits and procedures.
- •11.Life expectancy greater than 6 months (as per the PI?s discretion).
排除标准
- •1.Subjects who had central nervous system (CNS) metastases and subjects with any psychiatric disorders.
- •2.Subjects with previous or concurrent malignancy other than lung cancer, with the exception of non melanoma skin cancer or curatively treated carcinoma in situ of the uterine cervix.
- •3.Subjects who have a history of any of the following conditions within 6 months prior to screening visit:
- •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.
- •4.Subjects who are on treatment with
- •a.Hormonal therapy, radiation therapy, immunotherapy, biological therapy, any investigational agent and major surgery within 4 weeks before screening visit.
- •b.Herbal preparations or any alternative medicine within 2 weeks prior to screening visit or during the study.
- •5.Subjects with concurrent serious infection especially tuberculosis.
- •6.Subjects with a history of preexisting renal and hepatic impairment (h/o hepatitis, alcoholism or liver cirrhosis).
- •7.Subjects with vascular (peripheral vasculitis and gangrene) and skin disorders.
- •8.Subjects who are planning or in need for a major surgical procedure or radiotherapy (RT) during the study.
- •9.Subjects who are pregnant or breast feeding.
- •10.Subjects with known history of hypersensitivity reactions to investigational drugs.
研究者
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