NCT00054314已完成2 期
An Uncontrolled, Phase II Study Evaluating Anti-Tumor Efficacy and Safety of BAY 59-8862 in Patients With Taxane Resistant Non-Small Cell Lung Carcinoma (NSCLC)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who have non-small cell lung cancer.
详细描述
OBJECTIVES:
- Determine the overall response rate, including partial and complete response, in patients with taxane-resistant non-small cell lung cancer treated with BAY 59-8862.
- Determine the overall survival of patients treated with this drug.
- Determine duration of response and time to progression in patients treated with this drug.
- Determine the quantitative and qualitative toxic effects of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive BAY 59-8862 IV over 1 hour on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients with responding disease receive 2-4 additional courses beyond maximal response.
Patients are followed every 3 months for 2 years and then every 6 months thereafter.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
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 or cytologically confirmed non-small cell lung cancer
- •Measurable disease
- •A CNS lesion cannot be the sole target lesion
- •Must be taxane-resistant as defined by the following criteria:
- •At least 1 prior course (3 weeks of continuous therapy) of a taxane
- •Progressive disease developed either during or within 6 months after therapy
- •No metastatic brain or meningeal tumors unless the following criteria apply:
- •More than 6 months since definitive therapy
- •Negative imaging study within the past 4 weeks
- •Clinically stable with respect to the tumor
- •No concurrent acute steroid therapy or taper
- •Chronic steroids allowed provided dose is stable for 1 month before and after screening radiography
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 9.0 g/dL
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •ALT and AST no greater than 2.5 times ULN (5 times ULN if liver involvement)
- •No chronic hepatitis B or C
- •Creatinine no greater than 1.5 times ULN
- •Cardiovascular
- •No congestive heart failure
- •No serious cardiac arrhythmias
- •No active coronary disease or ischemia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception
- •HIV negative
- •No active clinically serious infection
- •No history of seizure disorder
- •History of seizures related to brain metastasis allowed if seizure free for the past 2 months
- •No prior hypersensitivity to taxane compounds that was unmanageable with premedication
- •No pre-existing peripheral neuropathy greater than grade 1
- •No other malignancy within the past 3 years except carcinoma in situ of the cervix, adequately treated basal cell carcinoma, or superficial bladder tumors (Ta, Tis, and T1)
- •No substance abuse
- •No medical, psychological, or social condition that would preclude study participation or evaluation
- •No condition that is unstable or would jeopardize patient safety and study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 3 weeks since prior anticancer immunotherapy
- •More than 3 weeks since prior biologic response modifiers (e.g., filgrastim [G-CSF])
- •More than 4 months since prior bone marrow transplantation or stem cell rescue
- •No concurrent anticancer immunotherapy
- •Concurrent epoetin alfa allowed if dose is stable for the past 2 months
- 另有 21 项未显示
排除标准
- 未提供
研究者
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