EUCTR2004-000028-34-FI进行中（未招募）不适用
A randomised Phase 3 Trial of ALIMTA and Cisplatin versus GEMZAR and Cisplatin in Patients with locally advanced or metastatic Non-Small-Cell Lung Cancer
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,700
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
- •Histologic or cytologic diagnosis of NSCLC Stage IIIB or IV
- •No prior systemic chemotherapy for lung cancer
- •At least one unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST), longest diameter ,10 mm with spiral computed tomography (CT) scan, or ,20 mm with conventional techniques.Positron emission tomography (PET) scans and ultrasounds should not be used for lesion measurements.
- •ECOG performance status of 0 or 1
- •At least 18 years of age
- •Adequate organ function, including the following: Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ³1.5 ´ 109/L, platelets ³100 ´ 109/L, and hemoglobin ³9 g/dL.Hepatic: bilirubin £1.5 times the upper limit of normal (´ ULN), alkaline phosphatase (AP), aspartate transaminase (AST), and alanine transaminase (ALT) £3.0 ´ ULN (AP, AST, and ALT £5 ´ ULN is acceptable if the liver has tumor involvement)
- •Renal: calculated creatinine clearance (CrCl) ³45 mL/minute based on the standard Cockcroft and Gault formula (Cockcroft and Gault 1976).
- •Prior radiation therapy allowed to <25% of the bone marrow. Prior radiation to the whole pelvis is not allowed.Prior radiotherapy must be completed at least 4 weeks before study enrolment. Patients must have recovered from the acute toxic effects of the treatment prior to study enrolment.
- •Estimated life expectancy of > 12 weeks
- •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
- •Peripheral neuropathy of > CTC grade 1
- •Serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient’s ability to complete the study.
- •Serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV.
- •Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- •Documented brain metastatses unless the patient has completed successful local therapy for central nervous system metastases and has been off of corticosteroids for at least 4 weeks before enrollment. Brain imaging is required in symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients.
- •Presence of clinically detectable (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
- •Significant weight loss (that is > 10%) over the previous 6 weeks before study entry.
- •Concurrent administration of any other antitumor therapy.
- •Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for 5-day period (8-day period for long-actiong agents, such as piroxicam)
- •Inability or unwillingness to take folic acid or vitamin B12.
- •Inability to take corticosteroids
研究者
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