EUCTR2009-011580-36-PT进行中（未招募）不适用
Effectiveness of first line treatment with lapatinib and ECF/X in histologically provenadenocarcinoma of the stomach or the esophagogastric junction (metastatic or notamenable to curative surgery) according to HER2 and EGFR status: a randomizedphase II trial
EORTC - European Organisation for Research and Treatment of Cancer0 个研究点目标入组 350 人开始时间: 2010年10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
- 350
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 proven adenocarcinoma of the stomach or the esophagogastric junction, metastatic or not amenable to curative surgery
- •¨ Availability of tissue material for HER2 and EGFR assessment
- •¨ Former neoadjuvant/adjuvant chemotherapy allowed if completed = 12 months before inclusion to the study
- •¨ WHO Performance status 0-1
- •¨ Age 18 – 75 years
- •¨ Positive HER2 status by IHC, or positive EGFR by either FISH or IHC at time of randomization
- •¨ Absolute neutrophil count > 1.5 x 109/L, platelets > 100 x 109/L, hemoglobin > 9 g/dL, and white blood cell count (WBC) > 3 x 109/L within 3 weeks of randomization
- •¨ Renal function: Serum creatinine = 2.0 mg/dL and Calculated creatinine clearance = 60 ml/min (Cockcroft-Gault method, see appendix E) within 3 weeks of randomization
- •¨ Clinically normal cardiac function (LVEF assessed by MUGA or ECHO within 21 days prior to randomization)
- •¨ All patients (male and female) must use effective contraception methods if of reproducing potential for the whole duration of study and until 1 month after they received the last treatment dose; Females must not be pregnant or breast-feeding at anytime during the study. Women with reproductive potential must have a pregnancy test performed within 3 weeks before randomization.
- •¨ Ability to swallow and retain oral medication
- •¨ Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations
- •¨ All indicated timelines and absolute values requested by the eligibility criteria must be adhered to. However, a maximum of +/- 10% of the reference value for laboratory parameters and a maximum of +/- 2 days for timelines may be acceptable.
- •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
- •¨ Former palliative systemic chemotherapy
- •¨ Prior exposure to EGFR pathway targeting therapy (antibodies or tyrosine kinase inhibitors)
- •¨Use of drugs or herbal constituents known to be inducers or inhibitors of CYP3A4 within 30 days prior to initiation of treatment and during treatment with lapatinib
- •¨ Major hepatic insufficiency (bilirubin = 1.5 x ULN and aspartate aminotransferase
- •(ASAT)/alanine aminotransferase (ALAT) = 3 x ULN, = 5 x ULN in case of liver metastases) within 3 weeks prior to randomization
- •¨ Serious cardiac illness in the past 6 months
- •¨ Clinical signs of CNS involvement
- •¨ Previous or concurrent malignancies, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix or basal cell carcinoma of the skin
- •¨ Other anticancer therapy or other investigational agents while on study
- •¨ History or evidence of interstitial pneumonitis or pulmonary fibrosis
- •¨ Uncontrolled infections or serious illnesses, malabsorption syndrome or medical conditions including chronic alcohol abuse, hepatitis, HIV and/or cirrhosis
- •¨ Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule
研究者
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