NCT00098462撤回1 期
A Phase I/II Trial of ZD1839 (Iressa®) and Rapamycin (Rapamune) in Patients With Advanced Non Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Maximum tolerated dose (Phase I)
研究概览
简要总结
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as sirolimus, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes when chemotherapy is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to chemotherapy. Giving gefitinib together with sirolimus may reduce drug resistance and allow the tumor cells to be killed.
PURPOSE: This phase I/II trial is studying the side effects and best dose of sirolimus when given with gefitinib and to see how well they work in treating patients with recurrent or refractory stage IIIB or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of sirolimus when combined with gefitinib in patients with recurrent or refractory stage IIIB or IV non-small cell lung cancer.
Secondary
- Determine the overall response rate (complete response [CR] and partial response [PR]) in patients treated with this regimen.
- Determine the disease control rate (CR, PR, and stable disease) in patients treated with this regimen.
- Determine the time to progression and overall survival of patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed non-small cell lung cancer
- •Stage IIIB or IV disease
- •Recurrent or refractory disease
- •Received ≥ 1 prior platinum-containing chemotherapy regimen
- •Unidimensionally measurable disease that has not been irradiated
- •No newly diagnosed untreated brain metastases or spinal cord compression
- •Paraffin-embedded tumor tissue or slides available
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Adequate bone marrow function
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Adequate hepatic function
- •No severe or uncontrolled hepatic disease
- •Adequate renal function
- •Creatinine ≤ 3.0 times upper limit of normal
- •No severe or uncontrolled renal disease
- •Cardiovascular
- •Adequate cardiac function
- •No severe or uncontrolled cardiac disease
- •No uncontrolled hyperlipidemia
- •No unstable or uncompensated respiratory disease
- •No clinically active interstitial lung disease
- •Patients with chronic stable radiographic changes who are asymptomatic are eligible
- •Gastrointestinal
- •Able to take oral medication
- •No gastrointestinal condition (e.g., peptic ulcer disease) that would affect absorption
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No serious infection
- •No known severe hypersensitivity to gefitinib or any of its excipients
- •No other malignancy within the past 5 years except treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •No other severe or uncontrolled systemic disease
- •No significant clinical disorder or laboratory finding that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 14 days since prior biologic therapy
- •No prior cetuximab, panitumumab, or bevacizumab
- •Chemotherapy
- •See Disease Characteristics
- •More than 4 weeks since prior cytotoxic chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- 另有 23 项未显示
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose (Phase I)
次要结局
- Overall response (complete response [CR] and partial response [PR]) as measured by RECIST criteria
- Disease control rate (CR, PR, and stable disease) correlated with smoking history
- Time to tumor progression and overall survival
- Quality of life as assessed by the Functional Assessment of Cancer Therapy-Lung (FACT-L)
- Lung cancer subscale from FACT-L
研究者
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