A Randomized Phase II Trial of Weekly Gemcitabine, Paclitaxel and External Irradiation (50.4 GY) Followed by the Farnesyl Transferase Inhibitor R115777 (NSC #702818) for Locally Advanced Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Randomized phase II trial to compare the effectiveness of gemcitabine, paclitaxel, and radiation therapy with or without tipifarnib in treating patients who have locally advanced pancreatic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining chemotherapy and radiation therapy with tipifarnib may be an effective treatment for pancreatic cancer.
详细描述
OBJECTIVES:
I. Compare the 1-year survival rate in patients with locally advanced pancreatic cancer treated with paclitaxel, gemcitabine, and radiotherapy with or without tipifarnib.
II. Determine the toxicity and loco-regional activity of this chemoradiotherapy regimen in these patients.
III. Determine the feasibility and toxicity of prolonged administration of tipifarnib after chemoradiotherapy in these patients.
IV. Determine whether tipifarnib administered after chemoradiotherapy can increase progression-free and overall survival in these patients.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed unresectable, locally advanced adenocarcinoma of the pancreas
- •Residual disease after resection (R1 or R2, microscopic or macroscopic) allowed
- •No metastases in major viscera
- •No peritoneal seeding or ascites
- •Biliary or gastroduodenal obstruction must have drainage before starting study therapy
- •Radiographically assessable disease encompassable within a single irradiation field (15 by 15 cm maximum)
- •Performance status - Zubrod 0-1
- •Granulocyte count at least 1,800/mm^3
- •Platelet count at least 100,000/mm^3
- •ALT less than 3 times upper limit of normal
- •Bilirubin less than 2.0 mg/dL
- •Creatinine less than 3.0 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other malignancy within the past 2 years except non-melanoma skin cancer or carcinoma in situ of the cervix, uterus, or bladder
- •No significant infection or other medical condition that would preclude study
- •No prior chemotherapy (including gemcitabine or paclitaxel) for pancreatic cancer
- •No other concurrent cytotoxic agents
- •See Disease Characteristics
- •No prior radiotherapy to the planned field
- •No other concurrent radiotherapy
- •See Disease Characteristics
- •No other concurrent investigational agents
排除标准
- 未提供
研究组 & 干预措施
Arm I (radiation therapy, paclitaxel, gemcitabine)
Patients receive radiotherapy once daily, 5 days a week, for 5.5 weeks, beginning on day 1. Patients also receive paclitaxel IV over 1 hour and gemcitabine IV over 30 minutes on days 1, 8, 15, 22, 29, and 36.
干预措施: gemcitabine hydrochloride (Drug)
Arm I (radiation therapy, paclitaxel, gemcitabine)
Patients receive radiotherapy once daily, 5 days a week, for 5.5 weeks, beginning on day 1. Patients also receive paclitaxel IV over 1 hour and gemcitabine IV over 30 minutes on days 1, 8, 15, 22, 29, and 36.
干预措施: paclitaxel (Drug)
Arm I (radiation therapy, paclitaxel, gemcitabine)
Patients receive radiotherapy once daily, 5 days a week, for 5.5 weeks, beginning on day 1. Patients also receive paclitaxel IV over 1 hour and gemcitabine IV over 30 minutes on days 1, 8, 15, 22, 29, and 36.
干预措施: radiation therapy (Radiation)
Arm II (radiation therapy, tipifarnib)
Patients receive chemoradiotherapy as in arm I. Within 3-8 weeks after completion of chemoradiotherapy, patients without disease progression receive oral tipifarnib twice daily for 21 days.
干预措施: tipifarnib (Drug)
Arm II (radiation therapy, tipifarnib)
Patients receive chemoradiotherapy as in arm I. Within 3-8 weeks after completion of chemoradiotherapy, patients without disease progression receive oral tipifarnib twice daily for 21 days.
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Overall survival
时间窗: 1 year
Calculated along with associated 95% confidence intervals.
次要结局
- Progression-free survival(1 year)
- Difference in overall survival between treatment regimens(1 year)
- Frequency of patients developing unacceptable toxicity defined as grade 3 or higher gastrointestinal or pulmonary toxicity and/or discontinuation of treatment(Up to 5 years)