Phase II trial of paclitaxel (T) vs Irinotecan(I) in patients with previously Etoposide/platinum (EP) treated, extensive disease (ED) small cell lung cancer (SCLC) as 2nd line chemotherapy

Chung-Ang Univerisity Hospital0 个研究点目标入组 136 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

暂无简介。

•1) Histologically or cytologically diagnosed dilated stage small cell lung cancer patient
•2) Patients who were treated with etoposide / platinum combination therapy as a first-line treatment and who had more than partial response (PR) and sustained more than 90 days. However, it is a rule to keep it for more than 90 days, but it is also possible to register patients who are kept for more than 60 days.
•3) In the presence of brain metastases with neurological symptoms, previous radiation therapy or surgical treatment for brain metastases was neurologically stable (no progressive neurological symptoms, and steroid therapy was discontinued). Radiation therapy The researcher has determined that the toxicity of
•4) When radiation therapy is applied to areas other than the brain, it can be selected when the scope of irradiation does not include target lesions
•5) Appropriate bone marrow, liver, new function
•Serum creatinine ? Normal upper limit of each organ (UNL)
•Serum transaminase = UNL x 2.0 (if there is liver damage ? UNL x 5
•Serum bilirubin ? UNL x 1.5
•neutrophil count ? 1,500 / uL, platelets ? 100,000 / uL
•6) If there is more than one measurable lesion based on RECIST criteria
•7) 20 years old or older
•8) Eastern Cooperative Oncology Group (ECOG) Activity 0-2
•9) Have obtained written consent based on the guidelines of each institutional clinical trial committee

•1) Patients with brain metastases whose symptoms are not adequately controlled
•2) Patients with significant infectious disease to which parenteral antibiotics should be administered
•3) diarrhea patients whose symptoms are not adequately controlled
•4) Chronic inflammatory bowel disease whose symptoms are not adequately controlled
•5) Patients with bowel obstruction, bowel obstruction
•6) Patients with interstitial pneumonia or pulmonary fibrosis
•7) Patients with dialysis
•8) Pregnant or potentially pregnant women and lactating women
•9) Patients receiving Atazanavir Sulfate
•10) Patients who have a history of hypersensitivity reactions to xylitol or its components. Patients with a history of severe hypersensitivity to other drugs containing Cremophor® EL (polyoxyethylated castor oil)
•11) Large amount of ascites, pleural effusion
•12) Patients receiving St. John's Wort

发起方

Chung-Ang Univerisity Hospital