NCT00024427已完成3 期
An Open Label, Randomized, Controlled, Phase III, Multi-center, Clinical Trial Of PN401 With High Dose 5-Fluorouracil (5FU) Versus Gemcitabine For Treatment Of Patients With Advanced Pancreatic Cancer
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 57
- 主要终点
- Open Label Randomized Phase 3 Multi-Center Trial of PN401 plus high dose 5-FU versus Gemcitabine in Advanced Pancreatic Cancer Patients
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells. Chemoprotective drugs such as triacetyluridine may protect normal cells from the side effects of chemotherapy. It is not yet known which chemotherapy regimen is more effective in treating pancreatic cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil plus triacetyluridine with that of gemcitabine in treating patients who have locally advanced or metastatic pancreatic cancer that cannot be treated with surgery.
详细描述
OBJECTIVES:
- Compare the survival of patients with unresectable locally advanced or metastatic pancreatic cancer treated with triacetyluridine and high-dose fluorouracil vs gemcitabine.
- Compare the time to tumor progression, overall response rate, and response duration in patients treated with these regimens.
- Compare the safety of these regimens in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to disease stage (II or III vs IV). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive high-dose fluorouracil (5-FU) IV over 30 minutes once weekly on weeks 1-3 followed by 1 week of rest. After each dose of 5-FU, patients receive oral triacetyluridine every 8 hours for a total of 8 doses. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 followed by 1 week of rest (course 1). Subsequent courses are given on weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 adenocarcinoma of the pancreas
- •Unresectable locally advanced or metastatic disease
- •Stage II, III, or IV
- •Measurable or evaluable disease
- •No elevated tumor marker (CA 19-9) only
- •No clinically significant third-space fluid accumulation (e.g., ascites or pleural effusion)
- •No carcinoid, islet cell, or lymphoma of the pancreas
- •No prior or concurrent brain or leptomeningeal metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •WBC at least 3,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 9.5 g/dL
- •Bilirubin no greater than 2.0 mg/dL
- •ALT or AST less than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
- •No uncontrolled hepatic dysfunction
- •Creatinine less than 2.0 mg/dL
- •No uncontrolled renal dysfunction
- •Cardiovascular:
- •No uncontrolled cardiovascular disease requiring therapy, including the following:
- •Arrhythmias
- •Uncompensated cardiac failure
- •Myocardial infarction within the past 6 months
- •No uncontrolled pulmonary dysfunction
- •Gastrointestinal:
- •Able to take and/or retain oral medication
- •No uncontrolled malabsorption syndrome or any other condition that would interfere with intestinal absorption
- •No known allergy to fluorouracil (5-FU), gemcitabine, triacetyluridine, or any of their components
- •No dihydropyrimidine-dehydrogenase deficiency
- •No active uncontrolled infection
- •No uncontrolled neurologic or psychiatric dysfunction
- •No other malignancy except previously resected basal cell cancer or curatively resected stage I or less cervical cancer that has been disease free for at least 5 years
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent biologic therapy (including immunotherapy) for cancer
- •Chemotherapy:
- •No prior chemotherapy for cancer other than as a radiosensitizer
- •No prior 5-FU or gemcitabine other than as a radiosensitizer
- •No prior triacetyluridine
- •No other concurrent chemotherapy (including leucovorin calcium) for cancer
- 另有 12 项未显示
排除标准
- 未提供
结局指标
主要结局
Open Label Randomized Phase 3 Multi-Center Trial of PN401 plus high dose 5-FU versus Gemcitabine in Advanced Pancreatic Cancer Patients
时间窗: Disease progression
次要结局
未报告次要终点
研究者
研究点 (57)
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