临床试验/NCT00637910

NCT00637910Unknown3 期

Optimization of Erlotinib for the Treatment of Patients With Advanced Non Small Cell Lung Cancer: an Italian Randomized Trial

Fatebenefratelli and Ophthalmic Hospital103 个研究点分布在 1 个国家目标入组 850 人开始时间: 2007年11月最近更新: 2012年2月24日

适应症

干预措施

试验速览

阶段: 3 期
发起方
入组人数: 850
试验地点: 103
主要终点: Overall Survival

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The aim of this study is to assess the superiority of docetaxel in comparison to erlotinib in second line in wild-type EGFR tumour patients.

详细描述

Erlotinib is registered in all patients affected with NSCLC in second and subsequent lines with a small benefit on Overall Survival. Recent evidence suggest that patients with EGFR mutations have a clear benefit when they are treated with EGFR tyrosine kinase inhibitors, while the role of these drugs in wild-type EGFR patients, that are representing the large majority (about 85-90%), is still unclear and no properly planned trials assessed before this issue. Recently, indirect evidence on subgroup analyses on randomized trial suggest that chemotherapy might be superior to erlotinib in wild-type EGFR patients.

Moreover, several authors do not recommend the use of EGFR determined with immunohistochemistry (IHC) or FISH because they do not reproducibly predict outcome.

For these reasons the protocol was amended in May 2011 in a superiority trial of docetaxel versus erlotinib, while the first version was aimed to assess the interaction with biomarkers.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age 18 years or older
•Histological or cytological confirmation of NSCLC (may be from initial diagnosis of NSCLC or subsequent biopsy). Only patients with available tissue samples may be included in the study
•Absence of EGFR mutations of exons 19 or 21 (randomization)
•Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy
•One prior platinum-based at adequate doses and taxane free regimen
•Measurable (uni-dimensional) disease by RECIST in a lesion not previously irradiated or non-measurable disease
•ECOG-PS 0-2
•ANC greater than 1.5 x 109/L and platelets greater than 100 x 109/L
•Bilirubin level either normal or <1.5xULN
•AST (SGOT) and ALT (SGPT) <2.5xULN (≤5 x ULN if liver metastases are present)
•Serum creatinine <1.5xULN
•Effective contraception for both, male and female pts, if the risk of conception exists
•Recovery from all acute toxicities of prior therapies
•Provision of written informed consent to the analysis of biological markers (registration)
•Provision of written informed consent to enter the randomized part of the study (randomization)

排除标准

•Prior therapy with an experimental agent whose primary mechanism of action is inhibition of EGFR or its associated tyrosine kinase
•Prior chemotherapy with taxanes
•Newly diagnosed CNS metastases that have not yet been treated with surgery and/or radiation. Pts with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically SD (no steroid therapy or steroid dose being tapered) for at least 28 daysLess than 14 days since completion of prior radiotherapy or persistence of any radiotherapy related toxicity
•Any unresolved chronic toxicity from previous anticancer therapy that, in the opinion of the investigator, makes it inappropriate for the patient to be enrolled in the study Known severe hypersensitivity to erlotinib or any of the excipients of this product
•Known hypersensitivity to docetaxel, polysorbate 80 or other drugs formulated with polysorbate 80, or any of the excipients of docetaxel
•Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
•Unable to swallow tablets
•Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic or patients with uncomplicated progressive lymphangitic carcinomatosis need not be excluded)
•As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
•As judged by the investigator, any inflammatory changes of the surface of the eye
•Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study

研究组 & 干预措施

Erlotinib Arm

Experimental

干预措施: Erlotinib (Drug)

Docetaxel Arm

Active Comparator

干预措施: Docetaxel (Drug)

结局指标

主要结局

Overall Survival

时间窗: 12 months after the last patient is randomized

次要结局

Progression Free Survival(with 4 years and 12 months after the last patient is randomized)
Premature withdrawals(within 4 years)
Response assessed with RECIST criteria(within 4 years)
Quality of Life assessed with QLQ-C30 and QLQ-LC13 questionnaires(within 4 years)
Toxicity, graded according to the NCI-CTAE version 3.0(within 4 years)
Frequency and nature of serious adverse reactions(within 4 years)

研究者

发起方

Fatebenefratelli and Ophthalmic Hospital

申办方类型

Other

责任方

Principal Investigator

主要研究者

Scanni Alberto

Alberto Scanni MD

Fatebenefratelli and Ophthalmic Hospital

研究点 (103)

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