ISRCTN91946477已完成不适用
A phase I dose escalation study of cisplatin, pemetrexed and radiotherapy for inoperable stage III non-small cell lung cancer
Erasmus Medical Center (The Netherlands)0 个研究点目标入组 39 人开始时间: 2006年11月22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
- 39
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 diagnosis (bronchial brushings and washings or Computed Tomography (CT)-guided fine needle aspiration) of NSCLC, stage III which is not amenable to surgical resection
- •2. Uni-dimensional or bi-dimensional disease on CT scans of the chest. Measurable tumour and/or nodal mass not exceeding 6 cm in largest diameter
- •3. Received no prior chemotherapy or radiation therapy
- •4. Performance Status zero to one on the World Health Organisation (WHO) scale
- •5. Estimated life expectancy of at least 24 weeks
- •6. Patient compliance and geographic proximity that allow adequate follow-up
- •7. Adequate bone marrow reserve:
- •a. White blood count (WBC) more than or equal to 3.0 x 10^9/L
- •b. platelets more than or equal to 100 x 10^9/L
- •c. haemoglobin more than or equal to 6 mmol/L (³ 9.6g/dl)
- •8. Adequate respiratory function: Forced expiratory volume in one second (FEV1) more than or equal to 1.0 L/s (more than 30%) and transfer factor for carbon monoxide (DLCO) more than or equal to 40% of predicted
- •9. Aged 18 years or over
- •10. Written informed consent from patients
- •11. Effective use of contraception for both males and females if appropriate during and for three months following end of study
排除标准
- •1. Evidence of active infection at the discretion of the investigator
- •2. Inadequate liver function: bilirubin more than 1.5 times normal, Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) more than three times normal
- •3. Inadequate renal function: calculated creatinine clearance using Cockcroft-Gault formula of less than 60 ml/min
- •4. Hypercalcemia
- •5. Evidence of extrathoracic metastases/Stage IIIB with supraclavicular lymph nodes
- •6. Uncontrolled superior vena cava syndrome, haemoptysis causing a decrease of blood haemoglobin of more than or equal to 1 g/L (more than or equal to 0.062 mmol/L) in 24 hours, or other situations which make complete staging or treatment planning impossible
- •7. Pleural effusion with positive cytology
- •8. Pregnancy
- •9. Breast feeding
- •10. Serious concomitant systemic disorder incompatible with the study
- •11. Second primary malignancy (except in situ carcinoma of the cervix or adequately treated non-melanomatous skin cancer), unless off treatment and in remission for greater than five years
- •12. Use of any investigational agent in the month before enrolment into the study
- •13. Any co-morbid pulmonary disease that may put the patient at risk of toxicity, specifically interstitial lung disease (fibrosis) and serious chronic pulmonary disease
- •14. Patients who are unable to interrupt aspirin, other nonsteroidal anti-inflammatory drugs for a five day period starting two days before administration of pemetrexed (eight-day period for long acting agents such as piroxicam). Patients that cannot be treated with folic acid and vitamin B12 and dexamethasone
- •15. Presence of clinically detectable (by physical examination) third-space fluid collections, for example ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to the study entry
- •16. Use of growth factors
研究者
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