NCT00066313已完成2 期
A Phase II Study Of ZD6474 Or Placebo In Small Cell Lung Cancer Patients Who Have Complete Or Partial Response To Induction Chemotherapy +/- Radiation Therapy
Genzyme, a Sanofi Company42 个研究点 分布在 1 个国家开始时间: 2003年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 42
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: ZD6474 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. ZD6474 may also stop the growth of small cell lung cancer by blocking blood flow to the tumor.
PURPOSE: This randomized phase II trial is studying how well ZD6474 works compared to placebo in treating patients with small cell lung cancer that has responded to previous chemotherapy with or without radiation therapy.
详细描述
OBJECTIVES:
- Compare the progression-free survival of patients with previously treated small cell lung cancer (SCLC) treated with ZD6474 vs placebo.
- Compare the response rate of patients treated with these regimens (only patients who had measurable disease outside a prior radiation field at study entry).
- Compare the toxicity and tolerability of these regimens in these patients.
- Compare the pharmacokinetics of these regimens in these patients.
- Correlate outcome and response with vascular endothelial growth factor expression and microvessel density in patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Provide a comprehensive tumor, plasma, and urine bank linked to a clinical database for further study of molecular markers in SCLC.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center, timing of prior radiotherapy (early [before day 1, course 4 of chemotherapy] vs late vs no prior radiotherapy), stage of disease at diagnosis (limited vs extensive), and response at study entry (complete vs partial). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral ZD6474 daily.
- Arm II: Patients receive oral placebo daily. In both arms, courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every 4 weeks while on therapy, and then every 8 weeks until disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 16 Years 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed small cell carcinoma of the lung
- •Small cell and variant histology allowed
- •No mixed tumors (small and large cell)
- •No neuroendocrine tumors of the lung
- •Must have received at least 4 courses of first-line combination chemotherapy as part of an induction regimen
- •No prior change in regimen due to disease progression
- •Must have achieved a radiologically confirmed (i.e., CT scan, chest x-ray, or bone scan) complete response (CR) or partial response (PR) after prior chemotherapy with or without radiotherapy AND meets 1 of the following criteria:
- •No more than 28 days since prior chemotherapy
- •At least 7 and no more than 14 days since prior radiotherapy if administered after completion of prior chemotherapy*
- •No CNS metastases
- •Asymptomatic patients with CNS metastases who received prior therapeutic cranial irradiation and are on stable, decreasing, or no steroids are eligible
- •No symptomatic lesions or evidence of necrosis or bleeding NOTE: *Randomization may take place up to 21 days after prior radiotherapy in the instance of severe esophagitis that precludes administration of oral medications
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •Absolute granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •No history of bleeding diathesis
- •Bilirubin less than 1.5 times upper limit of normal (ULN)
- •ALT less than 2.5 times ULN
- •Creatinine less than 1.5 times ULN
- •Calcium normal
- •Cardiovascular
- •No prior ventricular arrhythmia that was symptomatic or required treatment (CTC grade 3), including any of the following:
- •Multifocal premature ventricular contractions
- •Trigeminy
- •Ventricular tachycardia
- •No prior QT prolongation with any medication
- •No congenital long QT syndrome
- •No QT and QTc (with Bazett's correction) that is unmeasurable or is 460 msec or higher on screening ECG
- •No significant cardiac event, including symptomatic heart failure or angina, within the past 3 months or any cardiac disease that increases the risk for ventricular arrhythmia
- •No ongoing chronic atrial fibrillation
- •LVEF at least 45% by MUGA for patients with significant cardiac history (myocardial infarction, severe hypertension, or arrhythmia) OR who received prior doxorubicin greater than 450 mg/m^2
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Potassium normal
- •Magnesium normal
- •No serious active infection
- •No recent major bleeding
- •No other concurrent serious underlying medical condition that would preclude study participation
- •Willing and able to complete quality of life questionnaires in English or French
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior signal transduction inhibitors
- •No prior angiogenesis inhibitors
- •No concurrent anticancer biologic therapy or immunotherapy
- 另有 26 项未显示
排除标准
- 未提供
结局指标
主要结局
Progression-free survival
次要结局
- Toxicity and safety
- Overall Survival
- Response rates
- Quality of life (QOL) as measured by EORTC QLQ-C30 and QLQ-LC13
- Pharmacokinetics
研究者
研究点 (42)
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