ISRCTN38269072已完成不适用
A randomised phase II study of pemetrexed compared to pemetrexed-carboplatin in pretreated patients with advanced non-small cell lung cancer
VU University Medical Centre (The Netherlands)0 个研究点目标入组 230 人开始时间: 2007年4月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 230
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. Histologically or cytologically confirmed NSCLC locally advanced and metastatic disease stage IIIB and IV, with evidence of disease progression after cytotoxic treatment which should have included a platinum agent
- •2. At least three months from prior chemotherapy with complete recovery from first line chemotherapy side effects to less than grade two
- •3. At least one unidimensionally measurable leasion meeting Response Evaluation Criteria in Solid Tumours (RECIST) criteria
- •4. Eastern Cooperative Oncology Group (ECOG) performance status zero to two
- •5. Aged greater than 18 years
- •6. Adequate organ function, including:
- •a. adequate bone marrow reserve: Absolute Neutrophil Count (ANC) greater than 1.5 x 10^9/L, platelets greater than 100 x 10^9/L
- •b. hepatic: bilirubin less than 1.5 x Upper Limit of Normal (ULN), Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) less than 3.0 x ULN. AP, ALT, and AST less than 5 x ULN is acceptable if the liver has tumour involvement
- •c. renal: calculated creatinine clearance greater than 45 ml/min based on the Cockroft and Gault formula
- •7. Signed informed consent
- •8. Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate. Female patients with childbearing potential must have a negative serum pregnancy test within seven days prior to study enrolment
- •9. Estimated life expectancy greater than 12 weeks
- •10. Patient compliance and geographical proximity that allow adequate follow up
排除标准
- •1. Pregnant or lactating women
- •2. Patients who are poor medical risks because of non-malignant disease as well as those with active uncontrolled infection
- •3. Documented brain metastases unless the patient has completed local therapy for central nervous system metastases and has been off corticosteroids for at least two weeks before enrolment
- •4. Concomitant treatment with any other experimental drug under investigation
- •5. Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a five-day period (eight day period for long-acting agents such as piroxicam)
- •6. Inability or unwillingness to take folic acid, vitamin B-12 supplementation or dexamethasone
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