A Phase II Study of Temozolomide and Radiation Therapy in Patients With Brain Metastasis From Non-small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 主要终点
- Number of Patients With Intracranial Response
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as temozolomide may make the tumor cells more sensitive to radiation therapy. Combining temozolomide with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving temozolomide together with whole-brain radiation therapy works in treating patients with brain metastasis secondary to non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the intracranial response rate in patients with brain metastasis secondary to non-small cell lung cancer treated with whole brain radiotherapy and temozolomide.
Secondary
- Determine the time to radiological progression in patients treated with this regimen.
- Determine the time to neurological progression (confirmed by magnetic resonance imaging (MRI)) in patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
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 non-small cell lung cancer (NSCLC), including the following histologies:
- •Squamous cell carcinoma
- •Adenocarcinoma
- •Large cell carcinoma
- •Bronchoalveolar carcinoma
- •All variants of NSCLC
- •At least 1 bidimensionally measurable brain metastasis
- •Confirmed by MRI within the past two weeks, and computed tomography (CT) scan is not acceptable
- •Biopsy is not required
- •Not eligible for surgical resection or radiosurgery of brain metastasis
- •Systemic disease not in immediate need of chemotherapy
- •Age>=18 years
- •ECOG Performance status of 0-1
- •More than 12 weeks of life expectancy
- •Adequate hematologic, renal, and liver function as demonstrated by laboratory values performed within two weeks, inclusive, prior to administration of study drug or registration
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 10 g/dL
- •Bilirubin ≤ 2 times upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2 times upper limit of normal (5 times ULN if liver metastases are present)
- •Alkaline phosphatase ≤ 2 times ULN (5 times ULN if liver metastases are present)
- •Creatinine ≤ 1.6 mg/dL
- •Fertile patients must use effective contraception
- •Prior biologic therapy allowed
- •More than 4 weeks since prior chemotherapy
- •Prior radiotherapy for local control or palliative therapy for painful bony lesions allowed
- •Prior surgery for brain metastasis allowed
- •At least 4 weeks since prior radiotherapy to ≥ 15% of bone marrow (2 weeks for < 15% of bone marrow) and recovered
- •No prior radiotherapy to ≥ 50% of bone marrow
- •Concurrent radiotherapy to painful bony lesions allowed provided no more than 15% of bone marrow is irradiated
排除标准
- •HIV positive
- •AIDS-related illness
- •Poor medical risks due to active nonmalignant systemic disease
- •Frequent vomiting
- •There is medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction)
- •Pregnant or nursing
- •Prior temozolomide
- •Prior radiotherapy to the brain, including stereotactic radiosurgery to a different lesion
- •Concurrent intensity modulated radiotherapy or 3-D cranial radiotherapy
- •Other concurrent investigational agents
- •Other concurrent treatment for brain metastasis
- •Other concurrent chemotherapy during study radiotherapy
- •Concurrent growth factors to induce elevations in blood counts for the purposes of administration of study drug at scheduled dosing interval or to allow treatment with study drug at a higher dose
研究组 & 干预措施
Temozolomide and Radiation
Temozolomide:administered orally. Radiation: whole brain radiation therapy
干预措施: Temozolomide (Drug)
Temozolomide and Radiation
Temozolomide:administered orally. Radiation: whole brain radiation therapy
干预措施: Radiation therapy (Radiation)
结局指标
主要结局
Number of Patients With Intracranial Response
时间窗: assessed every cycle while on treatment, then every 3 months for 2 years
Response was assessed per Response Evaluation Criteria in Solid Tumor (RECIST) by brain MRI in the 21 eligible and treated patients.Complete response (CR): complete disappearance of the clinically detectable malignant brain metastasis(es) being followed on MRI scan off corticosteroids and a stable or improving neurologic exam. Partial response (PR): greater than or equal to a 50% reduction in the sum of the product(s) of the maximal cross-sections on MRI scan with a stable or decreasing dose of corticosteroids and a stable or improving neurologic exam. Response = CR + PR
次要结局
- Time to Non-CNS (Systemic) Progression(assessed every 3 months for 2 years)
- Overall Survival Time(assessed every 3 months for 2 years)
- 1-year Neurologic (Central Nervous System, CNS) Progression Free Rate(assessed every 3 months for 2 years)