EUCTR2006-002934-40-IT进行中（未招募）不适用
RANDOMIZED PHASE II TRIAL OF FIRST LINE CISPLATIN WITH DOCETAXEL OR VINORELBINE FOR 6 CYCLES IN PATIENTS WITH ADVANCED NON-SMALL-CELL LUNG CANCER - CISPLATIN WITH DOCETAXEL OR VINORELBINE in NSCLC
GOIM GRUPPO ONCOLOGICO MERIDIONALE0 个研究点开始时间: 2007年7月3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
- •Histologically or cytologically confirmed diagnosis of NSCLC; 2. Histologic subtypes may include large cell, squamous cell, or adenocarcinoma or a generic cytological diagnosis of NSCLC; 3. Patients must have a locoregionally advanced unresectable non metastatic NSCLC Stage IIIB only N3 supraclavicular or T4 for pleural effusion or Stage IV according to the revised International Staging System; 4. Patients must have at least one measurable lesion according to RECIST criteria. 5. Previous radical surgery more 30 days before study entry is allowed but a pathologic proof of progression of neoplastic disease must be documented; 6. Males or females aged between 18 and 70 years; 7. WHO Performance Status 0 or 1 Appendix I ; 8. Weight loss 5 within the last 3 months; 9. Laboratory requirements at entry - Blood cell counts Absolute neutrophils 2.0 . 109/L; Platelets 100 . 109/L; Hemoglobin 10 g/dl - Renal function Serum creatinine 1 upper normal limits UNL . In case of limit value of serum creatinine, the creatinine clearance should be 60 mL/min - Hepatic functions Serum bilirubin 1 x UNL; ASAT and ALAT 2.5 x UNL; Alkaline phosphatase 5 x UNL unless accompanied by extensive bone metastases 10. Obtained signed informed consent prior to start protocol specific requirements; 11. Patient compliance and geographic proximity that allow adequate follow-up.
- •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
- •Prior systemic chemotherapy or immunotherapy. Prior neoadjuvant or adjuvant chemotherapy is allowed if ended at least 12 months before enrollment; 2. Prior radiotherapy for NSCLC to measurable lesions. Prior radiotherapy to 25 of the bone marrow is allowed in non target lesions. At least 4 weeks must be elapsed since the completion of the radiation therapy and the patient must have all side effects recovered. 3. Cyto-histological diagnosis of small cell lung cancer, carcinoid, or mixed small-cell / non-small cell lung cancer; 4. Patients with evaluable, not measurable disease only non target lesions ; 5. Patients with symptomatic brain metastases or with leptomeningeal disease; 6. History of prior malignancies, except for cured non melanoma skin cancer, curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years; 7. History of hypersensitivity reaction to polysorbate 80; 8. Pregnant or lactating women women of childbearing potential must use adequate contraception ; 9. Current peripheral neuropathy NCI grade 2; 10. Significant neurological or psychiatric disorders such as dementia that would prohibit them to understanding or rendering informed consent or from fully complying with treatment and follow-up; 11. Participation in clinical trials with other experimental agents within 30 days of study entry; 12. Other serious concomitant illness of medical conditions a Congestive heart failure or angina pectoris except if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmia; b History of significant neurologic or psychiatric disorders including demential or seizures; c Active infection requiring iv antibiotics; d Active ulcer, unstable diabetes mellitus or other contra-indication to corticotherapy; e Any other condition which in the judgement of the investigator would place the subject at undue risk or interfere with the study.
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