Phase II Study of Paclitaxel, Oxaliplatin, Leucovorin and 5-Fluorouracil (POLF) in Gemcitabine-Refractory Advanced Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Median survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, oxaliplatin, leucovorin and 5-fluoruracil, work in different ways separately and in combination to stop tumor cells from dividing so they stop growing or die. The use of metronomic dosing of chemotherapy minimizes side effects and increases efficacy by anti-angiogenic effects. The pilot study demonstrated promising responses in all patients. It is not yet known how effective this drug and dosing combination is in treating advanced pancreatic cancer.
PURPOSE: This non-randomized phase II trial is studying giving weekly doses of paclitaxel, oxaliplatin, leucovorin and 5-fluorouracil together as second or third-line therapy in treating patient with locally advanced unresectable or metastatic adenocarcinoma of the pancreas following demonstrated progression after first-line gemcitabine.
详细描述
OBJECTIVES:
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The primary objective is to determine the effectiveness the chemotherapy combination in improving the experience of those with advanced pancreatic cancer in
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Pain control and other aspects of quality of life
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Reduction of the tumor size or stabilization of tumor growth
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Progression free survival
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Overall survival
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The secondary objective is to determine the safety of this chemotherapy combination by monitoring and the managing the potential side effects
DOSE REGIMEN OUTLINE: Paclitaxel 60mg/m2 IV weekly; Oxaliplatin 50mg/m2 IV weekly; Leucovorin 20 mg/m2 IV weekly, minimum of 40 mg; 5FU 425mg/m2 IV weekly; Weekly for 12 weeks; Calcium and magnesium 1gram each IV prior to and after Oxaliplatin therapy; Glutathione 1500mg/m2 prior to Oxaliplatin
DURATION OF STUDY PERIOD: Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay greater than 3 weeks, 12 weeks initially, can than continue at discretion of investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS
- •Patients with pathologically-proven pancreatic adenocarcinoma, who
- •are not candidate for surgery
- •are not candidate for radiation therapy and
- •have failed gemcitabine-based chemotherapy regimen
- •Gender Eligible for Study:
- •Prior Therapy:
- •For advanced disease allowed as above;
- •Oxaliplatin or 5-FU will be allowed but a subset analysis will be done for this group of patients;
- •Tarceva and/or Erbitux allowed, but subset analysis will be done.
- •No known allergy to one of the study drugs
- •PATIENT CHARACTERISTICS:
- •No CNS metastases
- •No peripheral neuropathy > grade 2
- •ECOG Performance Status <=2
- •No other serious concomitant illness
- •Fully recovered from any prior therapy
- •Lower Age Limit:
- •Upper Age Limit:
- •Laboratory:
- •ANC >1500
- •Platelets >75,000
- •Creatinine <=2.0
- •For female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception
排除标准
- •Performance state >=3
- •Uncontrolled serious concomitant disease
- •Radiotherapy within the 6 weeks before Cycle 1' Day 1
- •Surgery within the 2 weeks before Cycle 1' Day 1
结局指标
主要结局
Median survival
Progression free survival
Clinical response rate (PS improvement by ECOG score, analgesic dose reduction)
Response Rate Recist (Uni-Dimensional) Criteria
Overall survival
Quality of life
次要结局
- Tolerance and Safety NCI-CTC version 2