EUCTR2007-001069-14-DE进行中（未招募）不适用
A phase II open-label, multi-centre, randomised, prospective, parallel-group study comparing Topotecan/Carboplatin administered 5 days versus 3 days versus Topotecan monotherapy daily x 5 as second line treatment for patients with relapsed extensive disease small cell lung cancer - Top Challenge
Aktion Bronchialkarzinom e.V.0 个研究点开始时间: 2007年11月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Pre-treated histologically confirmed small cell lung cancer (cytological diagnoses is
- •permitted only in definitely and doubtless cases)
- •Relapse or progression of small cell lung cancer at least 60 days after day 1 of
- •the last cycle of first-line therapy.
- •ECOG Performance Status < 2
- •Life expectancy not less than 2 month
- •No contraindication against any study medication used in this study
- •No more than one previous chemotherapy with a minimum of 4 and a maximum of
- •6 cycles. The previous chemotherapy had to be platin-based.
- •Age = 18 years
- •Extensive disease at the time of relapse with indication to systemic
- •chemotherapy
- •Adequate haematological parameters:
- •- Leukocytes: >3.500 µl
- •- Neutrophiles: >1.500 µl
- •- Platelets: >100.000 µl
- •- Hemoglobin >9 g/dl (to reach a Hb of 9 g/dl it is permittet to
- •perform a transfusion of pRBCs or to
- •apply Erythropoietin (EPO)
- •Adequate hepatic laboratory parameters:
- •- Bilirubin : <1,5 x ULN
- •- Alk. Phosphatase: <3,0 x ULN
- •Adequate renal laboratory parameters:
- •- Creatinin-Clearance > 60 ml/min
- •Provision of informed consent according to local regulatory requirements prior to
- •any protocol specific treatment
- •Measurable lesion according to RECIST-Criteria
- •Negative pregnancy test for women of childbearing potential unless they are
- •postmenopausal at baseline. (Postmenopausal women must have been
- •amenorrheic at least for 12 months to be considered of non childbearing
- •Women of child bearing potential must be willing to use an acceptable method to
- •avoid pregnancy at least one month before study start. Examples: oral
- •contraceptives (sole application of oral contraceptives is not sufficient),
- •diaphragm pessary, intrauterine device (spiral), condom plus diaphragm pessary
- •plus spermicide.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients without a previous chemotherapy
- •More than one previous chemotherapy
- •Patients with a previous radiotherapy (>25% Irradiation of bone marrow) within
- •6 weeks prior to study start
- •Other co-existing malignancies or malignancies diagnosed within the last 5 years
- •with the exception of non-melanomatous skin cancer or cervical carcinoma of the
- •cervix after curative therapy.
- •Pregnancy or lactation period or lack of effective contraception
- •Active infections prior to study start
- •Respiratory insufficiency
- •Cardiac insufficiency and NYHA III und IV
- •Known active Hepatitis B or Hepatitis C or HIV-Infection
- •Known hypersensitivity to any of the study drugs
- •Life expectancy less than 2 month
- •Patients with symptoms of CNS metastases or leptomeningeal metastasis
- •receiving more than 12 mg/day dexamethasone
- •History of a mental disease or condition such as to interfere with the patient's
- •ability to understand the requirements of the study protocol
- •Patients with any clinically significant disease that is in the opinion of the
- •investigator likely to put the patient at risk or to interfere with the evaluation of
- •the patient's safety and of the study outcome.
- •Concurrent participation in an other clinical trial
- •Participation in another clinical trial within the last 4 weeks
- •Male trial subjects not willing to use an acceptable method to avoid pregnancy of
- •his wife/partner
- •Alcohol an drug abuse
研究者
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