A Phase II Trial of Novel Oral Anti-Angiogenic Agent AZD2171 (NSC-732208) in Malignant Pleural Mesothelioma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Overall Response Rate
研究概览
简要总结
This phase II trial is study how well AZD2171 works in treating patients with malignant pleural mesothelioma that cannot be removed by surgery. AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor
详细描述
PRIMARY OBJECTIVES:
I. Determine the objective confirmed, complete, and partial response rates in patients with unresectable malignant pleural mesothelioma treated with AZD2171.
SECONDARY OBJECTIVES:
I. Determine the clinical benefit, in terms of objective response and stable disease rates, in patients treated with this drug.
II. Determine the 1-year median overall survival and progression-free survival in patients treated with this drug.
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
- •Histologically confirmed epithelial, sarcomatous, or biphasic malignant pleural mesothelioma
- •Unresectable disease
- •Residual disease after prior cytoreductive surgery allowed
- •Measurable disease by CT scan or MRI
- •Prior treatment with platinum-based chemotherapy required
- •No known CNS metastasis
- •Performance status
- •Zubrod 0-2
- •WBC >= 3,000/mm^3
- •Absolute neutrophil count >= 1,500/mm^3
- •Platelet count >= 100,000/mm^3
- •AST or ALT =< 1.5 times upper limit of normal (ULN)
- •Bilirubin normal
- •Creatinine =< 1.5 times ULN OR
- •Creatinine clearance >= 50 mL/min
- •Proteinuria =< 1+ by 2 consecutive dipstick tests taken >= 1 week apart
- •No history of familial long QT syndrome
- •Mean QTc =< 470 msec
- •Systolic BP =< 150 mm Hg AND diastolic BP =< 100 mm Hg
- •Must have New York Heart Association class I or II disease
- •Class II must be controlled with treatment
- •Able to swallow and/or receive enteral medications via gastrostomy feeding tube
- •Not requiring IV alimentation
- •No active peptic ulcer
- •No intractable nausea or vomiting
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in remission
- •No history of hypersensitivity reaction to compounds of similar chemical or biological composition to the study drug
- •Prior monoclonal antibody therapy targeting vascular endothelial growth factor (VEGF), VEGF receptor 1(VEGFR1) or VEGF receptor 2 (VEGFR2) allowed
- •No other prior immunotherapy or biologic therapy
- •No prior thymidine kinase inhibitor against VEGFR1 or VEGFR2
- •No concurrent drugs or biologics with proarrhythmic potential
- •No more than 1 prior chemotherapy regimen
- •At least 28 days since prior chemotherapy (42 days for nitrosoureas or mitomycin) and recovered
- •At least 21 days since prior radiotherapy and recovered
- •At least 28 days since prior major surgery (e.g., thoracotomy or laparotomy) and recovered
- •No prior surgery that would affect absorption
- •Stable antihypertensive therapy allowed provided blood pressure (BP) parameters are met
- •Concurrent enrollment on SWOG-S9925 allowed
- •No concurrent combination antiretroviral therapy for HIV-positive patients
排除标准
- 未提供
研究组 & 干预措施
Treatment (cediranib maleate)
Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: cediranib maleate (Drug)
Treatment (cediranib maleate)
Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Overall Response Rate
时间窗: Disease assessments for response were performed every 8 weeks for as long as the patient remained on protocol treatment, up to 5 years.
confirmed complete and partial responses per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.".
次要结局
- Progression-free Survival(Every 8 weeks until disease progression or death, up to 5 years.)
- Adverse Event Rates(Daily during protocol treatment)
- Adverse Events(Patients were assessed for adverse events every day for as long as they remained on protocol treatment, up to 5 years.)
- Disease Control Rate(Every 8 weeks until disease progression progression, up to 5 years.)
- Overall Survival(Daily during protocol treatment; then every 8 weeks until progression; then every 6 months for up to 3 years.)
- Objective Response Rate Per Modified RECIST for Pleural Tumors(Disease assessments for response were performed every 8 weeks as long as the patient remained on protocol treatment, up to 5 years.)