NCT00551252Unknown2 期
A Phase II Study of the Association of Glivec® (Imatinib Mesylate, Formerly Known as STI 571) Plus Gemzar® (Gemcitabine) in Patients With Unresectable, Refractory, Malignant Mesothelioma Expressing Either PDGFR-Beta or C-Kit
Gruppo Italiano MEsotelioma1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2008年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
The purpose of this study is to evaluate the antitumor activity of a combination of Imatinib mesylate and Gemcitabine in patients with unresectable malignant mesothelioma expressing either PDGFR-beta or C-kit
详细描述
TITLE "A phase II study of the association of Glivec® (Imatinib mesylate, formerly known as STI 571) plus Gemzar® (Gemcitabine) in patients with unresectable, refractory, malignant mesothelioma expressing either PDGFR-beta or C-Kit"
PURPOSE Primary objective of the phase II
> Efficacy, i.e., response rate to study drugs
Secondary objectives of the phase II
- Duration of response
- Time to progression
- Toxicity profile
- Overall survival
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of > 18 years and < 72 years
- •Patients with a histologically proven malignant mesothelioma of the pleura or of the peritoneum, expressing either PDFGR-beta or C-Kit by immunochemistry (ICH)
- •Locally advanced disease, unsuitable for curative surgical resection, or metastatic disease
- •Confirmed progression of the disease according to modified REcist-criteria, documented after a first-line, systemic (premetrex+cisplatin regimen) or local treatment (i.e., intrapleuric)
- •ECOG Performance Status of 0, 1 or 2
- •Life expectancy of at least 3 months
- •Capability of understanding the objectives of the study and giving written informed consent
- •Willingness and ability to comply with study requirements
- •Sufficient caloric and fluid intake, including patients under enteral or parenteral nutrition
排除标准
- •Co-existing tumors of different histologic origin, except non melanomatous localized skin cancer and/or in situ cervical carcinoma
- •A history of earlier tumors of different histologic origin being in complete remission since less than 5 years
- •Unresolved toxicity from prior antitumor treatment(s)
- •Primary peritoneal mesothelioma
- •Any of the following abnormal baseline hematological values:
- •Hb < 9 g/dL
- •WBC < 3 x 109/L
- •Neutrophils < 1.5 x 109/L
- •Platelets < 100 x 109/L
- •Serum bilirubin > 2.5 mg/dL
- •ALAT and ASAT > 3 x UNL (unless due to liver metastases)
- •Serum creatinine > 1.5 mg/dL
- •Clinically relevant cardiovascular disease, i.e., myocardial infarction or other severe coronary artery diseases within the prior 6 months, cardiac arrythmia requiring medication, uncontrolled hypertension, overt cardiac failure or non compensated chronic heart disease in NYHA class II or more
- •History of psychiatric disabilities, potentially interfering with the capability of giving adequate informed consent
- •Pregnant or lactating women or inability/unwillingness to practice a medically approved method of contraception during study period (including 3 months following the end of treatment)
- •Uncontrolled active infections
- •Any condition which, in the judgement of the Investigator, would place the patient at undue risk or interfere with the results of the study
研究组 & 干预措施
I
Experimental
干预措施: Imatinib mesylate plus Gemcitabine (Drug)
结局指标
主要结局
Overall response rate
时间窗: Every two months
次要结局
- Progression-free-survival; Overall Survival; Safety(Follow-up after end of treatment will be every three months; safety will be analyzed throughout the whole study)
研究者
研究点 (1)
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