NCT00005027已完成2 期
A Phase II Study of Rebeccamycin Analog in 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
- 2
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 rebeccamycin analog in treating patients who have advanced kidney cancer.
详细描述
OBJECTIVES:
- Determine the response rate of patients with advanced renal cell carcinoma when treated with rebeccamycin analogue.
- Assess the quantitative and qualitative toxicities associated with this drug in this patient population.
OUTLINE: Patients receive rebeccamycin analogue IV over 30-60 minutes daily for 5 days. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 23-44 patients will be accrued for this study within 9-18 months.
研究设计
- 研究类型
- Interventional
- 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 locally advanced unresectable, locally recurrent, or metastatic renal cell carcinoma not eligible for a higher priority trial
- •Measurable disease
- •Longest diameter at least 20 mm with conventional techniques or at least 10 mm with spiral CT scan
- •No nonmeasurable disease only including:
- •Bone lesions
- •Leptomeningeal disease
- •Pleural/pericardial effusion
- •Lymphangitis cutis/pulmonis
- •Abdominal masses not confirmed and followed by imaging techniques
- •Cystic lesions
- •No known brain metastases
- •History of brain metastases that have been resected and/or irradiated with subsequent normal brain CT scan allowed
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •ECOG 0-2 OR
- •Karnofsky 60-100%
- •Life expectancy:
- •Greater than 12 weeks
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 mg/dL
- •AST/ALT no greater than 2.5 times upper limit of normal
- •Creatinine no greater than 1.5 mg/dL OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •No symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No other prior malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of any site
- •No history of allergic reactions attributed to compounds of similar chemical or biologic composition to rebeccamycin analogue
- •No other concurrent uncontrolled illness (e.g., ongoing or active infection)
- •No concurrent psychiatric illness or social situation that would preclude study compliance
- •HIV negative
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Prior biologic therapy allowed
- •Recovered from toxic effects
- •Chemotherapy:
- •No prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior radiotherapy and recovered
- •See Disease Characteristics
- •No other concurrent investigational or commercial agents or therapies for renal cell cancer
排除标准
- 未提供
研究者
研究点 (2)
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