Phase I/II Study of Gleevec (Imatinib Mesylate, Formerly Known as STI571) and Gemcitabine for Advanced Pancreas Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Determine maximum tolerated dose according to toxicity
研究概览
简要总结
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving imatinib mesylate together with gemcitabine may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of giving imatinib mesylate together with gemcitabine and to see how well they work in treating patients with locally advanced, metastatic, or recurrent pancreatic cancer.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of imatinib mesylate and gemcitabine hydrochloride in patients with locally advanced, metastatic, or recurrent pancreatic cancer.
- Determine the clinical response rate in patients treated with this regimen.
- Determine the 6-month and overall survival of patients treated with this regimen.
Secondary
- Determine the toxicity profile of this regimen in these patients.
- Correlate response with expression of platelet-derived growth factor (PDGF) and PDGF receptor in tumor tissue from patients treated with this regimen.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed pancreatic cancer
- •Locally advanced, metastatic, or recurrent disease
- •Measurable or evaluable disease by physical exam, plain radiographs, CT scan, or MRI
- •No brain metastases
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy of 12 weeks or greater
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
- •No chronic liver disease (i.e., chronic active hepatitis or cirrhosis)
- •Creatinine ≤ 2.0 mg/dL
- •No chronic renal disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier-method contraception during and for ≥ 3 months after completion of study treatment
- •No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
- •No uncontrolled diabetes
- •No active uncontrolled infection
- •No other severe and/or uncontrolled medical disease
- •HIV negative
- •PRIOR CONCURRENT THERAPY:
- •No prior therapy for metastatic disease
- •Prior fluorouracil as a radiosensitizer for adjuvant therapy after surgery or for locally advanced disease is permitted if local disease has recurred or progressed ≥ 3 months after completion of therapy or disease is present outside the radiation field
- •At least 2 weeks since prior major surgery
- •No concurrent grapefruit or grapefruit juice
排除标准
- 未提供
结局指标
主要结局
Determine maximum tolerated dose according to toxicity
时间窗: After 1 cycle of therapy (1 cycle = 21 days)
Clinical response rate
时间窗: After every 2 cycles of study therapy (1 cycle = 21 days)
Overall survival at 6 months
时间窗: After 6 months of study treatment
次要结局
未报告次要终点