NCT00027638已完成2 期
Phase II Trial Of Thalidomide In Patients With Low Grade Neuroendocrine Tumors (Carcinoid and Islet Cell Cancers)
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: Thalidomide may stop the growth of neuroendocrine tumors by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have metastatic neuroendocrine tumors.
详细描述
OBJECTIVES:
- Determine the safety and efficacy of thalidomide in patients with metastatic low-grade neuroendocrine tumors.
OUTLINE: Patients receive oral thalidomide once daily on weeks 1-8. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 14-25 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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed low-grade neuroendocrine tumors
- •Carcinoid tumors
- •Islet cell tumors
- •Metastatic disease
- •Progression of disease within past 4 weeks by radiological evidence
- •At least 1 bidimensionally measurable lesion by CT scan or MRI
- •Bone metastasis not considered measurable if only site of disease
- •No active brain metastases
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •More than 3 months
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin normal
- •AST no greater than 2.5 times upper limit of normal (ULN)
- •Creatinine no greater than 1.5 times ULN OR
- •Creatinine clearance at least 50 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use 2 forms of effective contraception for 4 weeks before, during, and for 4 weeks after study
- •No grade 2 or greater neuropathy
- •No other clinical circumstances that would preclude study
- •No other prior malignancy except:
- •Non-melanoma skin cancer
- •Other cancer that has been curatively treated, has had no evidence of recurrence within the past 5 years, and is at low risk for recurrence
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior thalidomide
- •No concurrent interferon
- •Chemotherapy:
- •No concurrent chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy
- •No concurrent radiotherapy
- •At least 4 weeks since prior major surgery
- •No more than 1 prior systemic therapy regimen
- •At least 4 weeks since prior systemic therapy regimen
- •No other concurrent therapeutic agent
排除标准
- 未提供
研究者
研究点 (1)
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