Gemcitabine With or Without Imatinib Mesylate in Treating Patients With Metastatic or Unresectable Kidney Cancer
A Phase II Trial of Gemzar (Gemcitabine) and Gleevec (Imatinib Mesylate) in Patients With Metastatic Renal Cell Carcinoma
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.
研究概览
详细说明
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.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by histology (clear cell vs nonclear cell) and prior therapy (immunotherapy/chemotherapy vs targeted agents).
Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate on days 1-5 and 8-12. Treatment repeats every 21 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving partial or complete response after 2 courses of treatment continue treatment with gemcitabine hydrochloride and imatinib mesylate in the absence of disease progression or unacceptable toxicity. Patients with stable disease after 2 courses of treatment are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV on days 3 and 10.
- Arm II: Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate on days 1-5 and 8-12.
In both arms, treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.
Available archived tumor tissue samples are obtained for immunohistochemical analysis to quantify the expression of c-KIT and platelet-derived growth factor receptor-alpha protein expression.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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New Jersey
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New Brunswick、New Jersey、美国、08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
- At least 28 days since prior and no other concurrent investigational or commercial agents, unless disease is rapidly progressing
No concurrent therapeutic warfarin
- Concurrent low molecular weight heparin or heparin allowed for therapeutic anticoagulation
- Concurrent prophylactic warfarin therapy ≤ 1 mg daily to maintain catheter patency allowed
- No concurrent filgrastim (G-CSF) for prevention of neutropenia
- No other concurrent chemotherapy, immunotherapy, hormonal cancer therapy, radiation therapy, or cancer surgery
- No concurrent routine use (i.e., daily or every other day) of systemic corticosteroid therapy (in supraphysiologic doses)
- No concurrent medication that would preclude study compliance
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
研究衡量的是什么?
主要结果指标
结果测量 |
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客观反应
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病情稳定
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次要结果测量
结果测量 |
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反应速度
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无进展生存期
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中位生存期
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Expression of c-KIT and platelet-derived growth factor receptor-alpha protein expression
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合作者和调查者
调查人员
- 首席研究员:Mark Stein, MD、Rutgers Cancer Institute of New Jersey
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CDR0000539400
- P30CA072720 (美国 NIH 拨款/合同)
- CINJ-080507
- CINJ-5633
- CINJ-NJ3805
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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