NCT00064051已完成2 期
A Phase II Study of Triapine in Combination With Gemcitabine in Patients With Pancreatic Cancer
Vion Pharmaceuticals14 个研究点 分布在 3 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
- 14
- 主要终点
- Objective response rate (partial and complete response) as assessed by RECIST criteria
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: This phase II trial is studying how well giving gemcitabine together with 3-AP works in treating patients with unresectable or metastatic pancreatic cancer.
详细描述
OBJECTIVES:
- Determine the objective response rate (partial and complete response) in patients with unresectable or metastatic pancreatic cancer treated with 3-AP and gemcitabine.
- Determine the progression-free interval and survival of patients treated with this regimen.
- Determine the safety and feasibility of this regimen in these patients.
OUTLINE: This is a multicenter study.
- Stage I: Patients receive 3-AP IV over 4 hours and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
- Stage II: Patients receive a higher dose of 3-AP IV continuously over 24 hours on days 1, 8, and 15. Within 1 hour of completing 3-AP administration, patients receive gemcitabine IV over 30 minutes on days 2, 9, and 16. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 month, every 2 months for 6 months, and then every 3 months for 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:
- •Histologically or cytologically confirmed pancreatic cancer
- •Unresectable or metastatic disease
- •Measurable disease
- •Outside prior radiation ports OR within prior radiation port if evidence of disease progression after radiotherapy
- •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
- •AST and ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN in the presence of liver metastases)
- •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 arrhythmias
- •No dyspnea at rest
- •No dependence on supplemental oxygen
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after study participation
- •No other malignancy except any of the following:
- •Carcinoma in situ of the cervix treated with cone biopsy or resection
- •Nonmetastatic basal cell or squamous cell skin cancer
- •Any stage I malignancy curatively resected more than 5 years ago
- •No active infection
- •No known or suspected glucose-6-phosphate dehydrogenase deficiency
- •No other concurrent life threatening illness
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Prior vaccines, antibodies, cytokines, or small molecule cell signaling inhibitors allowed
- •Chemotherapy
- •No prior cytotoxic chemotherapy for unresectable or metastatic pancreatic cancer
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Disease Characteristics
- •More than 4 weeks since prior radiotherapy and recovered
- •No concurrent radiotherapy
- •More than 3 weeks since prior surgery and recovered
- •More than 3 weeks since prior noncytotoxic treatment regimens and objective evidence of progressive disease
- •No other concurrent investigational drugs
排除标准
- 未提供
结局指标
主要结局
Objective response rate (partial and complete response) as assessed by RECIST criteria
次要结局
- Progression-free and overall survival
- Safety and feasibility
研究者
研究点 (14)
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