NCT00864721已完成2 期
Phase II Trial of Sunitinib Malate in Previously Untreated NSCLC Patients Over the Age of 70
US Oncology Research13 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2009年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 13
- 主要终点
- Disease Control Rate (DCR)
研究概览
简要总结
The purpose of this research study is to find out what effects (good and bad) sunitinib has on patients and their NSCLC.
详细描述
In this trial, the activity and tolerability of sunitinib malate (Sutent) will be examined in previously untreated elderly patients (>70 years old) felt not to be candidates for standard cytotoxic chemotherapy.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has measurable, metastatic NSCLC, other elderly NSCLC patients over 70 years of age who are not felt to be candidates for standard chemotherapy at the discretion of the treating physician may also be enrolled as long as they meet the criteria; these "special consideration" patients enrollment in the study must be approved by Dr. Reynolds or DR. Smith in Dr. Reynolds absence. Patients must have a nonsquamous histology to be eligible for this study.
- •Has not received any prior chemotherapy for the current disease.
- •Has an ECOG Performance status. Is 70 years of age or older.Has resolution of all acute toxic effects of radiotherapy or surgical procedures to NCI CTCAE.
- •If fertile, patient (males only) has agreed to an acceptable method of birthcontrol to avoid pregnancy for the duration of the study and for a period of 2 months thereafter.
- •Has signed the most recent Patient Informed Consent Form. Has signed a Pate int Authorization Form.
排除标准
- •Has predominantly squamous NSCLC histology.
- •Had prior treatment with study drugs or other drugs.
- •Has a history of hypersensitivity to any component of the study drug. Has any evidence of an of antecedent hemoptysis, squamous histology, or ongoing anticoagulation or clotting diathesis.
- •Pre-existing hemoptysis Grade 2, cavitating lesions or clear proximity or involvement of blood vessels.
- •Has had major surgery or radiation therapy within 4 weeks of starting the study treatment.
- •Has had NCI CTCAE (Version 3.0) Grade 3-4 hemorrhage within 4 weeks of starting the study treatment.
- •Has a history of or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan; however, treated, stable, and asymptomatic brain metastases are allowed.
- •Has had any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism. Has ongoing cardiac dysrhythmias of NCI CTCAE (Version 3.0) Grade
- •Has prolonged QTc interval on baseline EKG. Has uncontrolled hypertension.
- •Has pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication.
- •Is receiving concurrent treatment on another clinical trial.
- •Supportive care trials or non-treatment trials, (eg, QOL), are allowed.
- •Is receiving concurrent immunotherapy, hormonal therapy, or radiation therapy.
- •Is receiving concurrent investigational therapy or has received such therapy within the past 30 days.
- •Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection.
- •Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs.
- •Is unable to comply with requirements of study
研究组 & 干预措施
Sunitinib Malate
Experimental
Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.
干预措施: Sutent (Drug)
结局指标
主要结局
Disease Control Rate (DCR)
时间窗: Every 6 weeks until progressive disease or death due to any cause, up to 36 month.
Disease control rate = CR + PR + SD\>=6-weeks. 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. Stable Disease (SD) is defined as persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
次要结局
- Progression-free Survival (PFS)(All patients were followed until progressive disease or death, up to 36 months.)
- 1-year Overall Survival (OS) Rate.(All patients were followed until death or up to 36 months.)
- Overall Response Rates (OR)(Every 6 weeks until progressive disease or death due to any causes, up to 36 months.)
- Time to Progression (TTP)(All patients were followed until progressive disease or death, up to 36 months.)
研究者
研究点 (13)
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