NCT00077129已完成2 期
Phase II Trial Of Paclitaxel Plus Carboplatin In Patients With Metastatic Or Locally Advanced Collecting Duct Renal Cell Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 35
- 主要终点
- Proportion of patients with clinical response
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin works in treating patients with locally advanced or metastatic collecting duct renal cell cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Determine the response rate in patients with locally advanced or metastatic collecting duct renal cell cancer treated with paclitaxel and carboplatin.
Secondary
- Determine the tolerability of this regimen in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
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 confirmed collecting duct renal cell carcinoma
- •Advanced locally recurrent or metastatic disease
- •Not amenable to resection
- •Measurable disease
- •No active CNS metastases
- •Patients with CNS metastases previously treated with surgical resection and/or radiotherapy are eligible provided there is no evidence of disease progression by head CT scan or MRI at 3 months after the completion of definitive therapy
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC ≥ 3,000/mm^3
- •Absolute granulocyte count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST and ALT ≤ 2.5 times ULN
- •Creatinine ≤ 2 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No peripheral neuropathy greater than grade 1
- •No other prior malignancy except for curatively treated cancer from which the patient has been disease-free for the length of time considered appropriate for cure of the specific cancer
- •No known hypersensitivity to Cremophor EL
- •No active serious infection
- •No other serious underlying medical condition that would preclude study therapy
- •No dementia or significantly altered mental status that would preclude giving informed consent
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No more than 2 prior biologic response modifier (BRM) regimens
- •Regimens may have included interleukin-2 and/or interferon alfa
- •At least 4 weeks since prior BRM therapy
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Concurrent corticosteroids allowed
- •Radiotherapy
- •See Disease Characteristics
- •Prior radiotherapy allowed provided there is measurable disease that has not been irradiated OR there is clear evidence of tumor progression in an irradiated site
- •At least 4 weeks since prior radiotherapy
- •No concurrent external beam radiotherapy
- •See Disease Characteristics
- •No concurrent major surgery
- •No other concurrent anticancer drugs
排除标准
- 未提供
结局指标
主要结局
Proportion of patients with clinical response
次要结局
- Toxicity
研究者
研究点 (35)
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