NCT00004922已完成2 期
A Phase II Clinical Trial of Irinotecan (CPT-11) in Patients With Advanced High Grade Neuroendocrine Tumors
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
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 irinotecan in treating patients who have advanced neuroendocrine tumors.
详细描述
OBJECTIVES:
- Determine the efficacy of irinotecan in terms of tumor response, time to tumor progression, and survival in patients with advanced high grade neuroendocrine tumors.
- Evaluate the dose limiting and nondose limiting toxicities of this treatment regimen in this patient population.
OUTLINE: Patients receive irinotecan IV over 90 minutes once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed until death.
PROJECTED ACCRUAL: A total of 10-31 patients will be accrued for this study.
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 proven metastatic or unresectable high grade neuroendocrine tumor including:
- •Small cell carcinoma
- •Large cell neuroendocrine carcinoma
- •Other high grade neuroendocrine carcinomas without specification to cell size
- •No lung only involvement without any other primary site
- •No primary small cell lung cancer with or without metastases
- •Bidimensionally measurable disease with at least one lesion measuring at least 1 cm by 1 cm
- •High grade tumor indicated by at least one of the following:
- •Growth pattern suggestive of neuroendocrine differentiation
- •Mitotic rate greater than 15 mitoses per 10 hpf
- •Presence of abundant necrosis
- •Immunohistochemical evidence of neuroendocrine differentiation by positive staining for chromogranin, synaptophysin, or neuron specific enolase if no classic microscopic appearance of small cell carcinoma
- •No low grade neuroendocrine tumors (e.g., carcinoid tumors, pancreatic endocrine tumors) and atypical tumors
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 3,500/mm^3
- •Granulocyte count at least 1,500/mm^3
- •Platelet count at least 75,000/mm^3
- •Bilirubin no greater than upper limit of normal (ULN)
- •SGOT no greater than 5 times ULN
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular:
- •No myocardial infarction within the past 6 months
- •No uncontrolled congestive heart failure requiring therapy
- •No active or uncontrolled infection
- •HIV negative
- •No psychiatric or other disorder that would preclude study
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No more than 2 prior chemotherapy regimens
- •No prior camptothecins
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
排除标准
- 未提供
研究者
研究点 (1)
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