NCT00064064已完成2 期
A Phase II Study of Triapine in Combination With Gemcitabine in Patients With Metastatic Non-Small Cell Lung Cancer
Vion Pharmaceuticals10 个研究点 分布在 2 个国家开始时间: 2003年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 10
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and may help gemcitabine kill more cancer cells by making them more sensitive to the drug.
PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with 3-AP in treating patients who have metastatic non-small cell lung cancer.
详细描述
OBJECTIVES:
- Determine the partial and complete objective response rate in patients with metastatic non-small cell lung cancer treated with 3-AP and gemcitabine.
- Determine the progression-free and overall survival in patients treated with this regimen.
- Determine the safety of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive 3-AP IV over 4 hours followed by gemcitabine IV over 30 minutes once weekly on weeks 1-3. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 22-50 patients will be accrued for this study.
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 —（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
- •Metastatic disease
- •Progressive disease after no more than 2 prior cytotoxic regimens containing at least 1 of the following drugs:
- •Cisplatin
- •Carboplatin
- •Vinorelbine
- •Measurable disease
- •No CNS metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 9 g/dL (transfusion allowed)
- •Bilirubin no greater than 2.0 mg/dL
- •ALT and AST no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
- •Chronic viral hepatitis allowed
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular
- •No myocardial infarction within the past 3 months
- •No uncontrolled congestive heart failure
- •No uncontrolled coronary artery disease
- •No uncontrolled cardiac arrhythmias
- •No dyspnea at rest
- •No supplemental oxygen dependence
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after study participation
- •No active infection
- •No other prior or concurrent malignancy except carcinoma in situ of the cervix previously treated by cone biopsy and/or resection, nonmetastatic basal cell or squamous cell skin cancer, or any stage I malignancy curatively resected more than 5 years ago
- •No other concurrent life-threatening illness
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Prior non-cytotoxic biologic regimens allowed (e.g., vaccines, antibodies, cytokines, or small molecule cell signaling inhibitors)
- •Chemotherapy
- •See Disease Characteristics
- •More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- •No prior gemcitabine
- •No prior 3-AP
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •More than 4 weeks since prior radiotherapy and recovered
- •More than 3 weeks since prior surgery and recovered
- •More than 3 weeks since prior non-cytotoxic regimens
排除标准
- 未提供
研究者
研究点 (10)
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