A Phase II Trial of Cloretazine™ (VNP40101M) for Patients With Relapsed or Refractory Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 18
- 主要终点
- Overall response rate (complete and partial response)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as VNP40101M, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well VNP40101M works in treating patients with recurrent or refractory locally advanced or metastatic small cell lung cancer.
详细描述
OBJECTIVES:
- Determine the overall response rate (partial and complete) in patients with relapsed or refractory locally advanced or metastatic small cell lung cancer treated with VNP40101M.
- Determine the toxic effects of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to disease state (sensitive relapse [progressive disease > 3 months after responding to first-line chemotherapy] vs resistant disease [progressive disease during or ≤ 3 months after first-line chemotherapy]).
Patients receive VNP40101M IV over 15-30 minutes once weekly for 3 weeks. Treatment repeats every 6 weeks for up to 6 courses. Patients achieving a complete response (CR) receive 2 additional courses of therapy after CR.
After completion of study treatment, patients are followed periodically for up to 18 months.
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:
- •Cytologically confirmed small cell lung cancer
- •Locally advanced or metastatic disease
- •Recurrent or progressive disease after first-line standard cytotoxic therapy
- •Measurable or evaluable disease
- •Brain metastasis allowed
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy ≥ 2 months
- •Granulocyte count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Creatinine ≤ 2.0 mg/dL
- •Bilirubin ≤ 2.5 mg/dL
- •AST and ALT ≤ 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No active uncontrolled bleeding
- •No active infection
- •Must not require supplemental oxygen at rest
- •No active heart disease
- •No myocardial infarction within the past 3 months
- •No uncontrolled congestive heart failure
- •No uncontrolled arrhythmias
- •No uncontrolled coronary artery disease
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •More than 3 weeks since prior radiotherapy, biologic therapy or chemotherapy (6 weeks for nitrosoureas or mitomycin C)
- •Prior radiotherapy within the past 3 weeks allowed if exposure involves no more than 30% of bones with significant bone marrow-producing capabilities (e.g., vertebral bodies and long bones)
- •At least 2 weeks since prior surgery or hormonal therapy
- •Must not require any immediate palliative treatment including surgery
- •Must have recovered from prior anticancer therapy
- •Persistent, stable chronic toxic effects ≤ grade 1 are allowed
- •No more than 1 prior systemic chemotherapy regimen for locally advanced or metastatic disease
- •No other concurrent anticancer therapy
- •No other concurrent investigational agent
- •No concurrent disulfiram
排除标准
- 未提供
结局指标
主要结局
Overall response rate (complete and partial response)
Toxicity
次要结局
未报告次要终点