Phase II Study Of ZD1839 (NSC 715055) In Newly Diagnosed Patients With Glioblastoma (Grade 4 Astrocytoma)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Survival
研究概览
简要总结
Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of glioblastoma multiforme. Phase II trial to study the effectiveness of gefitinib in treating patients who have newly diagnosed glioblastoma multiforme.
详细描述
OBJECTIVES:
I. Determine treatment effectiveness of gefitinib, in terms of response rate, time to progression, survival at 52 weeks, progression-free survival at 6 months, and overall survival, in patients with newly diagnosed glioblastoma multiforme.
II. Determine the toxic effects of this drug in these patients. III. Assess fatigue, depression, excessive daytime somnolence, and quality of life in patients treated with this drug.
IV. Assess individual variation in responses, pharmacokinetic parameters, and/or biological correlates due to genetic differences in enzymes involved in transport, metabolism, and/or mechanism of action of this drug in these patients.
V. Determine if the type of epidermal growth factor receptor affects tumor response and outcome 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 newly diagnosed WHO grade IV astrocytoma (glioblastoma multiforme) or gliosarcoma
- •No WHO grade III anaplastic astrocytoma, oligodendroglioma, or mixed oligoastrocytoma
- •Completed standard external beam radiotherapy within the past 2-5 weeks
- •No evidence of tumor progression during radiotherapy
- •Performance status - ECOG 0-2
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10.0 g/dL
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •AST no greater than 3 times ULN
- •Creatinine no greater than 1.5 times ULN
- •No other active malignancy
- •No uncontrolled infection
- •No other severe concurrent disease that would preclude study participation
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No prior chemotherapy (including polifeprosan 20 with carmustine implant) for this tumor
- •See Disease Characteristics
- •No prior stereotactic radiosurgery or interstitial brachytherapy
- •No more than 15 weeks since prior surgery
排除标准
- 未提供
研究组 & 干预措施
Treatment (gefitinib)
Patients receive oral gefitinib daily. Courses repeat every 8 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
干预措施: gefitinib (Drug)
Treatment (gefitinib)
Patients receive oral gefitinib daily. Courses repeat every 8 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
干预措施: pharmacological study (Other)
Treatment (gefitinib)
Patients receive oral gefitinib daily. Courses repeat every 8 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
Treatment (gefitinib)
Patients receive oral gefitinib daily. Courses repeat every 8 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
干预措施: questionnaire administration (Other)
Treatment (gefitinib)
Patients receive oral gefitinib daily. Courses repeat every 8 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Survival
时间窗: 52 weeks
The proportion of 'successes' will be estimated using the binomial point estimator (number of 'successes' divided by the total number of evaluable patients) and standard binomial 90% confidence interval estimates. In the unlikely event that accrual has not been completed before the interim analyses are performed, the Duffy-Santner lgorithm will be used to calculate 90% confidence intervals.
次要结局
- Post-RT progression-time(From start of study therapy to date of disease progression or last follow-up, assessed up to 10 years)
- Toxicity patterns assessed using NCI CTC version 2.0(Up to 10 years)