NCT00323791终止2 期
A Phase II Trial of Gemzar (Gemcitabine) and Gleevec (Imatinib Mesylate) in Patients With Metastatic Renal Cell Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Stable disease
研究概览
简要总结
RATIONALE: 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. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying gemcitabine and imatinib mesylate to see how well they work compared with gemcitabine alone in treating patients with metastatic or unresectable kidney cancer.
详细描述
OBJECTIVES:
Primary
- Compare stable disease and objective response in patients with metastatic or unresectable renal cell carcinoma treated with gemcitabine hydrochloride with or without imatinib mesylate.
Secondary
- Evaluate the median survival, progression-free survival, and response rate in patients treated with gemcitabine hydrochloride and imatinib mesylate.
- Determine the qualitative and quantitative toxic effects of this regimen in these patients.
- Determine the expression of c-KIT and platelet-derived growth factor receptor-alpha protein expression in both tumor cells and associated endothelial cells using immunohistochemistry staining of paraffin-embedded tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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 renal cell carcinoma
- •Metastatic disease OR unresectable primary tumor
- •No known curative therapy exists
- •Documented progressive renal cell carcinoma as defined by RECIST criteria within the past 6 months
- •Measurable disease with ≥ 1 unidimensionally measurable lesion
- •No known symptomatic brain metastasis or untreated brain metastases or carcinomatous meningitis
- •Treated brain metastasis allowed provided the following criteria are met:
- •Clinically stable
- •More than 7 days since prior steroids
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy ≥ 3 months
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST and ALT ≤ 2.5 times ULN
- •Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective nonhormonal contraception during and for 3 months after completion of study treatment
- •Must be able to swallow oral medication
- •No coexisting medical condition that would preclude study compliance
- •No history of allergic reaction to compounds of similar chemical or biological composition to gemcitabine hydrochloride and/or imatinib mesylate
- •No uncontrolled illness that would preclude study participation
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia requiring therapy
- •No myocardial infarction within the past 6 months
- •No active infection
- •No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
- •No New York Heart Association class III-IV congestive heart failure
- •No known chronic liver disease (i.e., chronic active hepatitis or cirrhosis)
- •No known HIV positivity
- •No significant history of noncompliance to medical regimens
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Recovered from all prior therapy
- •No more than 3 prior treatment regimens, including any of the following:
- •No more than 1 prior cytotoxic therapy
- •Immunotherapy regimens comprising interferon and/or aldesleukin
- •Therapy with molecular targets
- •Any combination of the above treatments to a maximum of 3 total therapies
- •No prior gemcitabine hydrochloride for metastatic disease
- •No prior imatinib mesylate for metastatic disease
- •More than 2 weeks since prior major surgery
- •At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- •At least 3 weeks since prior anti-vascular endothelial growth factor therapy
- •At least 3 weeks since prior radiotherapy
- •Must have evidence of ≥ 1 measurable target lesion outside the radiation fields OR radiologically confirmed disease progression within the radiation fields after completion of radiotherapy
- 另有 8 项未显示
排除标准
- 未提供
结局指标
主要结局
Stable disease
Objective response
次要结局
- Median survival
- Progression-free survival
- Response rate
- Expression of c-KIT and platelet-derived growth factor receptor-alpha protein expression
研究者
研究点 (1)
Loading locations...
相似试验
终止
1 期
Gemcitabine and Pemetrexed Disodium in Treating Patients With Advanced Mycosis Fungoides or Sézary SyndromeLymphomaNCT00369629Northwestern University14
已完成
2 期
Gemcitabine, Bevacizumab, and Abdominal Radiation Therapy in Treating Patients With Localized Pancreatic CancerPancreatic CancerNCT00460174Northwestern University31
已完成
2 期
Gemcitabine and Erlotinib in Treating Patients With Metastatic or Recurrent Pancreatic CancerPancreatic CancerNCT00810719University of California, Davis30
终止
2 期
Gemcitabine +/- Imatinib Mesylate, Patients w/Previously Treated Metastatic Breast CancerBreast CancerNCT00323063Rutgers, The State University of New Jersey49
终止
1 期
Gemcitabine and Bevacizumab in Treating Patients With Pancreatic Cancer That Has Been Completely Removed By SurgeryPancreatic CancerNCT00410774University of California, San Francisco20