A Phase I Study Of ZD 1839 And Temozolomide For The Treatment Of Gliomas
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 11
研究概览
简要总结
RATIONALE: Biological therapies such as gefitinib may interfere with the growth of cancer cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib with chemotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining gefitinib with temozolomide in treating patients who have malignant primary glioma.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of gefitinib when given in combination with temozolomide in patients with malignant primary glioma.
- Determine the toxic effects of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a multicenter, dose-escalation study of gefitinib. Patients are stratified according to use of concurrent enzyme-inducing anti-epileptic drugs (yes vs no).
Patients receive oral gefitinib once daily on days 1-35 and oral temozolomide once daily on days 8-12 for the first course only. For the second and subsequent courses, patients receive oral gefitinib once daily on days 1-28 and oral temozolomide once daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of gefitinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed malignant primary glioma
- •Glioblastoma multiforme
- •Anaplastic astrocytoma
- •Anaplastic oligodendroglioma
- •Anaplastic mixed oligoastrocytoma
- •Malignant astrocytoma not otherwise specified
- •Stable or progressive disease
- •Progressive disease after interstitial brachytherapy or stereotactic radiosurgery must be confirmed by positron emission tomography or thallium scan, magnetic resonance spectroscopy, or surgical biopsy
- •Prior treatment for no more than 3 prior relapses allowed
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •More than 8 weeks
- •Hematopoietic:
- •WBC greater than 3,000/mm^3
- •Absolute neutrophil count greater than 1,500/mm^3
- •Platelet count greater than 120,000/mm^3
- •Hemoglobin greater than 10 g/dL (transfusion allowed)
- •Bilirubin less than 1.5 times upper limit of normal (ULN)
- •SGOT less than 1.5 times ULN
- •Creatinine less than 1.5 mg/dL OR
- •Creatinine clearance greater than 60 mL/min
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No active infection
- •No other concurrent significant medical illness that would preclude study participation
- •No significant gastrointestinal risk factors (e.g., active ulcerative colitis) within the past 6 months
- •No other malignancy within the past 3 years except non-melanoma skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 1 week since prior interferon
- •No concurrent filgrastim (G-CSF) during the first course of study therapy
- •Chemotherapy:
- •At least 2 weeks since prior vincristine
- •At least 3 weeks since prior procarbazine
- •At least 6 weeks since prior nitrosoureas
- •Prior or concurrent temozolomide allowed if there is no evidence of progression while receiving therapy
- •Endocrine therapy:
- •At least 1 week since prior tamoxifen
- •Must be on a stable dose of corticosteroids for at least 5 days
- •Radiotherapy:
- •See Disease Characteristics
- •At least 3 weeks since prior radiotherapy
- •See Disease Characteristics
- •At least 1 week since prior surgical resection
- •Recovered from all prior therapy
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排除标准
- 未提供