NCT00077415已完成2 期
A Randomized Phase II Study Of Triapine® Alone Versus Triapine and Gemcitabine As Second-Line Treatment Of Advanced Non-Small-Cell-Lung Cancer In Patients Who Had Prior Gemcitabine With Evaluation Of The Effect Of Triapine® On Gemcitabine Pharmacokinetics and Cellular Uptake In Peripheral Mononuclear Cells
Cancer Therapeutics Research Group15 个研究点 分布在 5 个国家目标入组 31 人开始时间: 2004年4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
- 入组人数
- 31
- 试验地点
- 15
- 主要终点
- Objective tumor response as assessed by RECIST criteria
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as 3-AP and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving 3-AP together with gemcitabine as second-line therapy works in treating patients with recurrent stage III or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the objective response rate in patients with stage III or IV recurrent non-small cell lung cancer treated with 3-AP (Triapine®) and gemcitabine as second-line therapy.
Secondary
- Determine the response duration, median time to progression, and overall survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the effect of 3-AP (Triapine®) on gemcitabine pharmacokinetics and cellular uptake into peripheral mononuclear cells in patients treated with this regimen.
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 (NSCLC)
- •Stage III or IV disease
- •One of the following cellular types:
- •Adenocarcinoma
- •Non-diffuse bronchoalveolar cell carcinoma
- •Large cell carcinoma
- •Squamous cell carcinoma NOTE: *A repeat biopsy of any accessible tumor site is required if > 5 years have elapsed since the initial diagnosis
- •Progressive disease after 1 prior gemcitabine-containing chemotherapy regimen for stage III or IV NSCLC and must have achieved, at least once, a partial response, complete response, or stable disease during therapy
- •Not a primary non-responder and experienced only progressive disease during gemcitabine-containing chemotherapy
- •Measurable disease
- •At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- •No known brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •ECOG 0-2 OR
- •Karnofsky 60-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC ≥ 3,000/mm^3
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •No glucose-6-phosphate dehydrogenase (G6PD) deficiency
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
- •Creatinine ≤ 1.5 times ULN OR
- •Creatinine clearance ≥ 50 mL/min
- •Cardiovascular
- •No prior uncontrolled cardiac disease
- •No myocardial infarction within the past 12 months
- •No symptomatic congestive heart failure
- •No coronary artery disease
- •No cardiac arrhythmia
- •No uncontrolled symptomatic pulmonary disease
- •No pulmonary disease that requires oxygen therapy
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other malignancy within the past 5 years except completely treated carcinoma in situ of the cervix or nonmelanoma skin cancer
- •No prior allergic reaction attributed to compounds of similar chemical or biological composition to study agents
- •No other concurrent uncontrolled illness
- •No psychiatric illness or social situation that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •See Disease Characteristics
- •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- 另有 8 项未显示
排除标准
- 未提供
结局指标
主要结局
Objective tumor response as assessed by RECIST criteria
次要结局
- Duration of overall response
- Pharmacokinetics
- Toxicity as assessed by NCI CTCAE v3.0
- Overall survival
- Median time to progression
研究者
研究点 (15)
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