NCT00041314已完成2 期
A Phase II Trial Of Carboplatin And Gemcitabine With Exisulind In Patients With Advanced Non-Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 79
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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of carboplatin, gemcitabine, and exisulind in treating patients who have advanced non-small cell lung cancer.
详细描述
OBJECTIVES:
- Determine the 18-month survival rate in patients with advanced non-small cell lung cancer treated with carboplatin, gemcitabine, and exisulind.
- Determine the feasibility and toxicity of this regimen in these patients.
- Determine the response rate, progression-free survival, and overall median survival of patients treated with this regimen.
OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1. Chemotherapy repeats every 21 days for up to 6 courses. Patients also receive oral exisulind twice daily beginning on day 1 of course 1 and continuing until disease progression or unacceptable toxicity occurs.
Patients are followed every 3 months for 2 years and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 6 months.
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 non-small cell lung cancer (NSCLC)
- •Unresectable stage IIIB (e.g., pleural effusion) not suitable for combined modality therapy OR
- •Prior brain metastases are allowed provided the following are true:
- •Patient completed radiotherapy and/or surgery at least 3 weeks prior to study
- •Objective evidence of resolution or significant improvement of brain lesions exists on follow-up CT scan or MRI
- •Patient is neurologically improved or stable
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute granulocyte count at least 1,500/mm^3
- •WBC at least 3,000/mm^3
- •Hemoglobin at least 9 g/L
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.25 mg/dL
- •SGOT no greater than 1.5 times upper limit of normal
- •Creatinine no greater than 2.0 mg/dL OR
- •Creatinine clearance at least 50 mL/min
- •Cardiovascular:
- •No prior uncontrolled cardiovascular disease
- •No hospitalization for acute myocardial infarction, arrhythmia, or congestive heart failure within the past 3 months
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective nonhormonal contraception
- •No serious active infection
- •No dementia or active psychoses
- •No other prior malignancy except nonmetastatic nonmelanoma skin cancer, carcinoma in situ of the cervix, or cancer curatively treated with surgery or small-field radiotherapy within the past 5 years
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •At least 3 weeks since prior radiotherapy
- •See Disease Characteristics
- •At least 1 month since prior investigational agents
- •More than 7 days since prior aspirin, sulindac, cyclo-oxygenase-2 (COX-2) inhibitors, or nonsteroidal anti-inflammatory drugs (except ibuprofen or naproxen)
- •No concurrent sulindac or COX-2 inhibitors
排除标准
- 未提供
研究者
研究点 (79)
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