NCT00005825Unknown2 期
Trans Retinoic Acid (Vesanoid) With Chemotherapy in Non-Small Cell Lung Cancer
Raghu Nandan, M.D., Inc2 个研究点 分布在 1 个国家开始时间: 1998年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 2
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 combination chemotherapy in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
- Determine the response rate and duration of response to mitomycin, vinorelbine, and cisplatin plus tretinoin in patients with stage IIIB or IV non-small cell lung cancer.
- Determine the toxicity of this treatment regimen in these patients.
- Determine survival of these patients with this treatment regimen.
OUTLINE: Patients receive tretinoin orally twice daily for 4 days starting days 1 and 8; cisplatin IV over 2 hours and vinorelbine IV on days 1 and 8; and mitomycin IV (courses 1 and 3) on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: At total of 15-46 patients will be accrued for this study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed stage IIIB or IV non-small cell lung cancer
- •Measurable disease
- •No brain metastases
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Zubrod 0-2
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute granulocyte count greater than 2,000/mm^3
- •Platelet count greater than 100,000/mm^3
- •Bilirubin less than 2 times upper limit of normal (ULN)
- •AST and ALT less than 2.5 times ULN (unless attributed to liver metastases)
- •Creatinine no greater than 1.5 mg/dL AND/OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •No myocardial infarction within past 6 months
- •No congestive heart failure
- •No uncontrolled arrhythmia
- •No other concurrent or prior malignancy within past 5 years except localized basal cell or squamous cell skin cancer
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy with clearly progressive disease
- •Concurrent palliative radiotherapy allowed if no evidence of disease progression
- •Not specified
排除标准
- 未提供
研究者
研究点 (2)
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