NCT00428896已完成2 期
A Pilot Feasibility Study to Evaluate the Efficacy of ZD1839 (IRESSA) in Eliminating Chemo- and Hormone- Resistant Cytokeratin-Positive Tumour Cells Circulating in the Blood of Women With Breast Cancer
University Hospital of Crete1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2005年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Efficacy of ZD1839 by quantitative analysis of CK-19 mRNA CTCs
研究概览
简要总结
Based on preclinical data, ZD1839 is considered a novel and promising therapeutic approach with potential application in the treatment of human breast cancer. Therefore it could be very important and clinically relevant to know if ZD1839 is capable of eliminating occult tumour cells circulating in the blood of breast cancer patients
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Provision of written informed consent
- •Histologically or cytologically confirmed breast cancer
- •Metastatic breast cancer (stage IIIB and IV)
- •Patients should have received at least one course of standard systemic chemotherapy for their metastatic disease. There should be at least one month between end of chemotherapy treatment and trial entry.
- •ER+ve patients should have received adjuvant hormonal treatment
- •Detection of CK-19 mRNA positive cells in the blood by real time PCR despite the previous administration of chemotherapy and if appropriate hormonal therapy
- •Aged 18 years and over
- •Paraffin-embedded tissue available for tumour histology (EGFR testing, ER, PgR, Her-2-neu testing)
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2
- •Patients willing to undergo regular detection of circulating occult tumour cells in the blood by immunocytochemistry and/or RT-PCR
- •Life expectancy of at least 12 weeks
排除标准
- •Any concurrent systemic treatment for breast cancer (including chemotherapy, radiotherapy, hormonotherapy, monoclonal antibodies)
- •Known severe hypersensitivity to ZD1839 or any of the excipients of this product
- •Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
- •Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- •Any unresolved chronic toxicity greater than common toxicity criteria (CTC) grade 2 from previous anticancer therapy (except alopecia)
- •Serum bilirubin greater than 1.5 times the upper limit of reference range (ULRR)
- •As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
- •Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 3 times the ULRR.
- •Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
- •Pregnancy or breast feeding (women of child-bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy
- •Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort
- •Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment
研究组 & 干预措施
1
Experimental
ZD1839
干预措施: ZD1839 (Drug)
结局指标
主要结局
Efficacy of ZD1839 by quantitative analysis of CK-19 mRNA CTCs
时间窗: Detection of CK-19 mRNA CTCs during and after the completion of ZD1839 treatment
次要结局
- To assess duration of response by means of CK-19 mRNA detection(6 months)
- To assess Progression Free Survival by means of CK-19 mRNA detection(1 year)
- To assess the safety of ZD1839 administration in this patient population(Toxicity assessment every month)
研究者
研究点 (1)
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