A Phase II Study Of Triapine For Advanced Adenocarcinoma Of The Pancreas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Survival in patients receiving triapine as first-line therapy
研究概览
简要总结
This phase II trial is studying how well triapine works as first-line or second-line therapy in treating patients with locally advanced or metastatic adenocarcinoma (cancer) of the pancreas. Drugs used in chemotherapy, such as triapine, work in different ways to stop tumor cells from dividing so they stop growing or die.
详细描述
PRIMARY OBJECTIVES:
I. Determine the 3- and 6-month survival rate of patients with locally advanced or metastatic adenocarcinoma of the pancreas treated with 3-AP (Triapine^®) as first- or second-line therapy.
SECONDARY OBJECTIVES:
I. Determine the toxicity and tolerability of this drug in these patients. II. Determine the time to treatment failure in patients treated with this drug. III. Determine overall survival and disease progression in patients treated with this drug.
IV. Determine tumor response in patients treated with this drug. V. Determine laboratory studies that will increase our understanding of Triapine and its effects on cellular processes.
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 pancreas
- •Unresectable disease
- •Locally advanced or metastatic disease
- •At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
- •Measurable lesions outside prior radiotherapy field OR measurable lesions actively growing in the site of prior radiotherapy
- •No prior chemotherapy OR previously treated with 1, and only 1, gemcitabine-containing regimen for metastatic, unresectable, or locally advanced pancreatic cancer
- •Adjuvant therapy not considered prior chemotherapy if all treatment was completed > 6 months before tumor recurrence
- •No known brain metastases
- •Performance status - ECOG 0-2
- •At least 6 weeks
- •Absolute neutrophil count >= 1,500/mm^3
- •Platelet count >= 75,000/mm^3
- •AST =< 3 times upper limit of normal (ULN)
- •Bilirubin =< 1.5 times ULN
- •Creatinine =< 1.5 times ULN
- •Creatinine clearance > 60 mL/min
- •No uncontrolled congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No pulmonary disease requiring oxygen
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No glucose-6-phosphate dehydrogenase (G6PD) deficiency (for patients of African, Asian, or Mediterranean origin or ancestry)
- •No active or ongoing infection
- •No hypersensitivity or severe allergic reaction to 3-AP (Triapine®) or related compounds
- •No concurrent uncontrolled illness
- •No psychiatric illness or social situation that would preclude study compliance
- •No other concurrent antineoplastic therapy
- •No concurrent combination antiretroviral therapy for HIV-positive patients
- •No other concurrent investigational therapy for the malignancy
排除标准
- 未提供
研究组 & 干预措施
Treatment (triapene)
Patients receive triapene IV over 2 hours on days 1-4 and 15-18. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: triapine (Drug)
结局指标
主要结局
Survival in patients receiving triapine as first-line therapy
时间窗: 6 months
The point estimate of the success rates will be calculated as the number of successes divided by the number of evaluable patients, with confidence intervals calculated by the method of Duffy and Santner.
Survival in patients receiving triapine as second-line therapy
时间窗: 4 months
The point estimate of the success rates will be calculated as the number of successes divided by the number of evaluable patients, with confidence intervals calculated by the method of Duffy and Santner.
次要结局
- Confirmed tumor response, defined to be a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart(6 months (first 6 courses of treatment))
- Incidence of adverse events assessed using CTCAE version 3.0(Up to 3 years)
- Time to treatment failure(Time from the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal, assessed up to 3 years)
- Overall survival(Up to 3 years)
- Time to disease progression(Time from registration to documentation of disease progression, assessed up to 3 years)