EUCTR2006-003568-73-FR进行中（未招募）不适用
Phase III, Multicenter, Open-label, Randomized Study of Erlotinib (Tarceva®) Treatment Versus Chemotherapy in Patients with Advanced Non-small-cell Carcinoma of the Lung Who Present Mutations in the Tyrosine Kinase (TK) Domain of Epidermal Growth Factor Receptor (EGFR)
Grupo Espagnol de Cancer de Pulmon0 个研究点目标入组 146 人开始时间: 2008年3月25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
- 入组人数
- 146
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. Before beginning the specific procedures of the protocol, informed consent must be obtained
- •in writing from the patient and documented before witnesses.
- •2. Histologic diagnosis of non-squamous-cell, non-small-cell lung cancer (NSCLC), stage IV or
- •stage IIIB with malignant pleural effusion or N3 tumors not candidates for thoracic irradiation
- •who present exon 19 deletions or exon 21 mutation in the tyrosine kinase domain of EGFR
- •3. Measurable or evaluable disease
- •4. Patients over 18 years
- •5. Performance status <= 2 on the ECOG scale
- •6. Adequate bone marrow reserve
- •b. Absolute neutrophil count > 1500/µL
- •c. Platelet count > 100,000/µL
- •7. Adequate kidney function: serum creatinine <= 1.5 x upper limit of normality (ULN)
- •8. Adequate liver function
- •9. Patients must be accessible for treatment and follow-up.
- •10. Patients capable of proper therapeutic compliance and accessible for correct follow-up.
- •11. Women of childbearing age must have a negative serum or urine pregnancy test within
- •7 days before beginning treatment.
- •12. Patients of both sexes of childbearing age, including women who had their last menstrual
- •period in the last 2 years, must use an effective contraceptive method.
- •13. Oral swallowing capability.
- •14. Patients with asymptomatic and stable cerebral metastases receiving medical treatment will be eligible for the study. Patients who have received radiation therapy for their cerebral metastases before the initiation of systemic treatment for non-small-cell lung cancer also will be eligible.
- •15. Absence of intestinal transit problems, such as malabsorption syndrome, chronic intestinal inflammatory disease, or other pathologies that, in the judgment of the investigator, can alter absorption of the medication.
- •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. Women who are pregnant or in the period of lactation.
- •2. Women of childbearing age who present a positive pregnancy test result in the baseline evaluation or who have not undergone this test.
- •3. Sexually active men and women (of childbearing age) who are not willing to use
- •contraceptive methods during the study.
- •4. Previous treatment with chemotherapy for metastatic disease. The administration of neoadjuvant or adjuvant chemotherapy is allowed as long as it has finalized ³ 6 months before entering the study.
- •5. Previous treatment with therapeutic agents targeting EGFR. Patients can have received radiotherapy as long as the irradiated lesion is not the only target lesion for evaluating response and as long as radiotherapy has been completed before initiating the study treatment (a 2-week period is recommended).
- •6. Treatment with an investigational drug agent during the 3 weeks before enrollment in the study.
- •7. Any known significant ophthalmologic anomaly of the ocular surface. The use of contact lenses is not recommended.
- •8. Pre-existent motor or sensorial neurotoxicity grade ³ 2 according to the NCI-CTCAE scale.
- •9. Evidence of spinal cord compression.
- •10. Incapacity to take oral medication or previous surgical procedures that affect absorption and imply the need for intravenous or parenteral feeding.
- •11. Other serious diseases or clinical conditions,
- •12. Absolute contraindication for steroid use.
- •13. Dementia or significantly disturbed mental state that could interfere with the patient’s understanding and granting of informed consent.
- •14. History of another neoplasm other than carcinoma in situ of the uterine cervix, basal cell skin carcinoma treated adequately, or prostate carcinoma with a good prognosis treated radically. History of another neoplasm treated curatively and without evidence of disease in the last 5 years.
研究者
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