NCT00016939已完成2 期
A Phase II Study of Flavopiridol 1 Hour Bolus Days 1-3 Q 21 Days in Patients With Advanced Renal Cell Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 201
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have unresectable or metastatic kidney cancer.
详细描述
OBJECTIVES:
- Determine the confirmed and unconfirmed complete and partial responses in patients with unresectable or metastatic renal cell cancer treated with flavopiridol.
- Determine the 6-month time to treatment failure rate and overall survival rate of patients treated with this drug.
- Determine the qualitative and quantitative toxic effects of this drug in this patient population.
- Determine, in a preliminary manner, the association of tumor response with pretreatment tumor proliferative and apoptotic rates in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed unresectable primary (M0) or metastatic renal cell cancer
- •At least 1 unidimensionally measurable lesion
- •At least 20 mm by conventional techniques OR
- •At least 10 mm by spiral CT scan
- •Soft tissue disease that has been previously irradiated within the past 2 months is not considered measurable
- •Soft tissue disease within a previously irradiated field is considered measurable provided disease has progressed and other measurable disease exists outside of the radiation field
- •No prior or concurrent brain metastases
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status:
- •Zubrod 0-2
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •No hypercoagulable state other than renal cell cancer
- •Not specified
- •Not specified
- •Cardiovascular:
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No prior isolated occurrence of deep venous thrombosis within the past 6 months
- •No prior isolated occurrence of pulmonary embolism within the past 6 months
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer in complete remission
- •No history of allergic reactions to compounds of similar chemical or biologic composition to flavopiridol (e.g., staurosporine, deschloroflavopiridol, or butyrolactone I)
- •No other uncontrolled illness (e.g., diabetes mellitus)
- •No ongoing or active infection
- •No psychiatric illness or social situation that would preclude study compliance
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •1 prior immunotherapy regimen comprising interferon and/or interleukin-2 allowed
- •At least 28 days since prior immunotherapy and recovered
- •No concurrent prophylactic filgrastim (G-CSF)
- •Chemotherapy:
- •No prior chemotherapy for renal cell cancer
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •At least 21 days since prior radiotherapy and recovered
- •See Disease Characteristics
- •Prior resection of primary tumor allowed
- •At least 28 days since prior surgery and recovered
排除标准
- 未提供
研究者
研究点 (201)
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