Phase II Trial Of Induction Gemcitabine/CPT-11 Followed By Twice-Weekly Infusion Gemcitabine And Concurrent External Beam Radiation For The Treatment Of Locally Advanced Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 7
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have locally advanced, unresectable pancreatic cancer.
详细描述
OBJECTIVES:
- Determine the time to progression, local control, and survival of patients with locally advanced, unresectable pancreatic cancer treated with induction gemcitabine and irinotecan followed by gemcitabine and concurrent radiotherapy.
OUTLINE: Patients receive induction gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Within 2 weeks of completing induction chemotherapy, patients receive gemcitabine IV over 30-60 minutes on days 1, 4, 8, 11, 15, 18, 22, 25, 29, and 32. Patients undergo concurrent radiotherapy 5 days a week for 5.5 weeks.
Patients are followed every 8 weeks for 6 months and then every 3 months for 1.5 years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed locally advanced pancreatic cancer
- •Regional (peri-pancreatic) lymph node involvement allowed
- •Clinically or surgically staged and considered unresectable or inoperable
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •More than 6 months
- •Hematopoietic:
- •Granulocyte count at least 1,500/mm3
- •Hemoglobin at least 10 g/dL
- •Platelet count at least 100,000/mm3
- •Not specified
- •Creatinine no greater than 2.0 mg/dL
- •Not pregnant
- •Fertile patients must use effective contraception
- •No other concurrent or prior malignancy within the past 2 years except nonmelanoma skin cancer or in situ carcinoma of the cervix or breast
- •No other serious medical or psychiatric illness that would preclude giving informed consent or limit survival to less than 2 years
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent anticancer immunotherapy
- •Chemotherapy:
- •No prior chemotherapy
- •No other concurrent anticancer chemotherapy
- •Endocrine therapy:
- •No concurrent anticancer hormonal therapy
- •Radiotherapy:
- •No prior abdominal-pelvic radiotherapy
- •No other concurrent anticancer radiotherapy
- •See Disease Characteristics
- •At least 3 weeks since prior open abdominal surgery
- •More than 10 days since prior laparoscopy
- •No other concurrent investigational drug
- •No concurrent participation in other clinical study
排除标准
- 未提供