Phase I study of irinotecan and cisplatin with concurrent thoracic radiotherapy in patients with limited-disease small cell lung cancer

Erasmus Medical Centre (The Netherlands)0 个研究点目标入组 9 人开始时间: 2007年4月11日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Cytologically or histologically proven SCLC
•2. Disease confined to one hemithorax without evidence of cytologically proven malignant pleural effusion
•3. No prior chemotherapy and/or radiotherapy
•4. Age 18 years or older
•5. Performance score zero or one
•6. Adequate organ functions:
•a. White Blood Cells (WBC) greater than 3.0 x 10^9/L
•b. Absolute Neutrophil Count (ANC) greater than 1.5 x 10^9/L
•c. platelets greater than 100 x 10^9/L
•d. serum creatinine less than 135 mmol/L or creatinine clearance according to Cockroft-Gault formula greater than 60 ml/min
•e. bilirubin less than 1.25 Upper Limit of Normal (ULN)
•f. Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT) less than 2.5 ULN
•g. Lactate Dehydrogenase (LDH) less than 1.25 ULN
•7. Adequate pulmonary function (Forced Expiratory Volume in one second [FEV1] greater than 30% of predicted, Diffusing capacity of the Lung for Carbon Monoxide [DLCO] greater than 40% of predicted)
•8. No prior malignancy unless five years in complete remission except for patients with prior breast cancer or melanoma. Patients with adequately treated basocellular carcinoma of the skin or cervical cancer are eligible
•9. Written informed consent

•1. Other serious illnesses
•2. Concurrent therapy with other anti-cancer drugs
•3. Pregnancy or lactation
•4. Presence of diarrhoea
•5. Presence of suspicion of bowel obstruction or chronic inflammatory bowel disease

发起方

Erasmus Medical Centre (The Netherlands)