Phase II Trial Evaluating Addition of Fulvestrant to Erlotinib in Patients With Stage IIIB/IV NSCLC Who Are Stable on Erlotinib and Exhibit Positivity for Estrogen or Progesterone Receptor
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Progression-free Survival
研究概览
简要总结
The main purpose of this research study is to see if adding fulvestrant (Faslodex) to erlotinib (Tarceva) is effective in patients with stage IIIb/IV Non-Small Cell Lung Cancer.
详细描述
Erlotinib is an oral drug which is able to block endothelial growth factor receptor (EGFR). EGFR stimulates cancer cell growth. Fulvestrant (faslodex) block estrogen hormone from gaining access to tumor and stimulating the tumor cells to grow. Both of these drugs are already approved by FDA but have not been studied in this combination.
We will study if the combination of these drugs will delay treatment failure. Lung cancer tumors in both males and females can be sensitive to estrogen. Only patients whose tumor expresses the estrogen will be eligible for the trial. Estrogen sensitivity will be tested on previously removed tumor specimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Estrogen or progesterone receptor positive stage IIIb/IV non-small cell lung cancer
- •Eligible patients will have stable disease on erlotinib monotherapy at FDA- approved doses after a minimum duration of erlotinib therapy of 2 months
- •18 years or older
- •ECOG Performance Status ≤2
- •Adequate Organ Function Requirements
- •Adequate coagulation function
- •Postmenopausal status in female patients is required and is defined as no menstrual periods for 12 month or surgical menopause
- •All patients must sign a written informed consent.
排除标准
- •Pregnant or breast-feeding women will not be entered on this study
- •Patients who are currently receiving another investigational drugs
- •Patients who are currently receiving other anti-cancer agents.
- •Hormone replacement therapy will not be allowed and have to be stopped 1 month prior to entry into the study
- •Patients who have an uncontrolled infection.
- •Patients receiving less than 100mg/day of erlotinib
- •Patients with evidence of progression after 2 months of erlotinib monotherapy.
- •Patients with a history of bleeding diathesis (i.e., disseminated intravascular coagulation [DIC], clotting factor deficiency) or long-term anticoagulant therapy (other than antiplatelet therapy).
- •Patients with a history of hypersensitivity to active or inactive excipients of fulvestrant (i.e. castor oil or Mannitol).
- •Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
研究组 & 干预措施
A
Single-arm study
干预措施: Fulvestrant and Erlotinib (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: 14 weeks after start of fulvestrant
次要结局
- Overall Survival(Patients will be followed until death)
研究者
Lyudmila Bazhenova, M.D.
Assistant Clinical Professor
University of California, San Diego