A Phase II Study Of Triapine In Combination With Cisplatin Esophageal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Objective response rate (CR + PR)
研究概览
简要总结
Drugs used in chemotherapy, such as 3-AP and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may help cisplatin kill more cancer cells by making them more sensitive to the drug. This phase II trial is studying how well giving 3-AP together with cisplatin works in treating patients with recurrent or metastatic adenocarcinoma of the esophagus or gastroesophageal junction.
详细描述
PRIMARY OBJECTIVES:
I. Determine the objective response rate in patients with recurrent or metastatic adenocarcinoma of the esophagus or gastroesophageal junction treated with 3-AP (Triapine) and cisplatin.
SECONDARY OBJECTIVES:
I. Determine the toxicity of this regimen in these patients. II. Determine the duration of response and overall survival of patients treated with this regimen.
III. Determine the palliative benefits with regard to dysphagia in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction
- •Metastatic or recurrent disease
- •Measurable disease
- •At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- •Outside prior irradiation port
- •No known brain metastases
- •Performance status - ECOG 0-2
- •Performance status - Karnofsky 50-100%
- •More than 6 months
- •Absolute neutrophil count ≥ 1,500/mm^3
- •WBC ≥ 3,000/mm ^3
- •Platelet count ≥ 100,000/mm^3
- •AST and ALT ≤ 2.5 times upper limit of normal
- •Bilirubin normal
- •Creatine normal
- •Creatinine clearance ≥ 50 mL/min
- •No prior myocardial infarction
- •No unstable angina
- •No cardiac arrhythmia
- •No uncontrolled congestive heart failure
- •No pulmonary disease requiring supplemental oxygen
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after study participation
- •No glucose-6-phosphate dehydrogenase (G6PD) deficiency (for patients of African, Asian, or Mediterranean origin)
- •No other concurrent uncontrolled illness
- •No active or ongoing infection
- •No active second malignancy
- •No prior allergic reaction to compounds of similar chemical or biological composition to 3-AP or other study agents
- •No psychiatric illness or social situation that would preclude study compliance
- •At least 1 year since prior platinum-derivative agents
- •No prior chemotherapy for metastatic or recurrent esophageal cancer
- •See Disease Characteristics
- •At least 2 weeks since prior radiotherapy and recovered
- •No other concurrent anticancer therapy
- •No other concurrent investigational agents
- •No concurrent combination antiretroviral therapy for HIV-positive patients
排除标准
- 未提供
研究组 & 干预措施
Treatment (triapine and cisplatin)
Patients receive 3-AP (Triapine) IV over 2 hours on days 1-4. Patients also receive cisplatin IV over 60 minutes on days 2 and 3 before 3-AP infusion. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: triapine (Drug)
Treatment (triapine and cisplatin)
Patients receive 3-AP (Triapine) IV over 2 hours on days 1-4. Patients also receive cisplatin IV over 60 minutes on days 2 and 3 before 3-AP infusion. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: cisplatin (Drug)
结局指标
主要结局
Objective response rate (CR + PR)
时间窗: Up to 2 years
Will be calculated together with 95% confidence intervals based on the binomial distribution.
Complete response rate
时间窗: Up to 2 years
Will be calculated together with 95% confidence intervals based on the binomial distribution.
次要结局
- Number of patients with improvement of dysphagia(Up to 2 years)
- Overall survival(Up to 2 years)
- Duration of response(From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 2 years)
- Number of patients with various treatment-related toxicities assessed using NCI CTCAE version 3.0(Up to 2 years)
- Progression-free survival(From the start of treatment to progression or death, assessed up to 2 years)
- Duration of improvement of dysphagia(Up to 2 years)