EUCTR2004-002943-28-LV进行中（未招募）不适用
A Randomized, Open Label, Parallel Group, International, Multicenter, Phase III Study of Oral ZD1839 (IRESSA®) Versus Intravenous Docetaxel (TAXOTERE®) in Patients With Locally Advanced or Metastatic Recurrent Non Small Cell Lung Cancer who have Previously Received Platinum Based Chemotherapy - INTEREST
适应症
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
- 1,440
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
- •1.Provision of written informed consent
- •2.Age 18 years or older
- •3.Histological or cytological confirmation of NSCLC (may be from initial diagnosis of NSCLC or subsequent biopsy). Note: sputum cytology alone is not acceptable. Cytological specimens obtained by brushing, washing or needle aspiration of a defined lesion are acceptable
- •4.Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy
- •5.One or two prior chemotherapy regimens, at least one of which must have been platinum-based.
- •6.Measurable (uni-dimensional) disease by RECIST criteria in a lesion not previously irradiated or non-measurable disease
- •7.WHO performance status (PS) 0-2
- •8.Absolute Neutrophil Count (ANC) greater than 1.5 x 10 to the power of 9/liter (L) and platelets greater than 100 x 10 to the power of 9/L
- •9.Adequate hepatic function, defined as BOTH a bilirubin less than or equal to upper limit of reference range (ULRR) AND an Eligible” combination of transaminases (aspartate aminotransferase (AST) or alanine aminotransferase (ALT)) and alkaline phosphatase (ALP).
- •10.Recovery from all acute toxicities of prior therapies
- •11.Life expectancy of at least 8 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
- •1.Prior ZD1839 therapy or prior therapy with an experimental agent whose primary mechanism of action is inhibition of EGFR or its associated tyrosine kinase
- •2.Prior docetaxel treatment for NSCLC
- •3.Newly diagnosed CNS metastases that have not yet been treated with surgery and/or radiation. Patients 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 days
- •4.Less than 14 days since completion of prior radiotherapy or persistence of any radiotherapy related toxicity
- •5.Less than 21 days since prior chemotherapy, immunotherapy or biological systemic anticancer therapy
- •6.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
- •7.Known severe hypersensitivity to ZD1839 or any of the excipients of this product
- •8.Known hypersensitivity to docetaxel, polysorbate 80 or other drugs formulated with polysorbate 80, or any of the excipients of docetaxel
- •9.Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- •10.Unable to swallow tablets
- •11.Any evidence of clinically active ILD (patients with chronic, stable, radiographic changes who are asymptomatic or patients with uncomplicated progressive lymphangitic carcinomatosis need not be excluded)
- •12.As judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg, unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
- •13.Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
- •14.Incomplete healing of the surgical incision from prior major surgery (small biopsy wounds will not prohibit the patient from study entry)
- •15.Signs of neurological symptoms consistent with new onset spinal cord compression
- •16.Patients with pre-existing peripheral neuropathy greater than or equal to grade 2 (NCI CTC criteria)
- •17.Pregnancy or breast feeding (women of child-bearing potential). Women of childbearing potential must practice acceptable methods of birth control throughout the study to prevent pregnancy
- •18.Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates or St John’s Wort
- •19.Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment
研究者
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