NCT00017199已完成2 期
Phase II Study of PS-341 in Metastatic 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
- 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 PS-341 in treating patients who have metastatic neuroendocrine tumors.
详细描述
OBJECTIVES:
- Determine the objective response rate of patients with metastatic neuroendocrine tumors treated with bortezomib.
- Determine the toxicity of this drug in this patient population.
- Determine the pharmacodynamics to correlate proteasome inhibition and efficacy of this drug in this patient population.
OUTLINE: This is a multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses beyond CR.
PROJECTED ACCRUAL: A total of 16-25 patients will be accrued for this study within 6 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 confirmed metastatic carcinoid tumor or islet cell tumor
- •Well-differentiated neuroendocrine tumor OR
- •Well-differentiated neuroendocrine carcinoma
- •Measurable disease in at least 1 dimension
- •At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- •The following are considered nonmeasurable:
- •Lesions in a previously irradiated area
- •Bone lesions
- •Leptomeningeal disease
- •Pleural/pericardial effusion
- •Lymphangitis cutis/pulmonis
- •Abdominal masses that are not confirmed and followed
- •Cystic lesions
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 6 months
- •Hematopoietic:
- •Leukocyte count at least 3,000/mm^3
- •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
- •Cardiovascular:
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No other uncontrolled illness
- •No ongoing active infection
- •No psychiatric illness or social situation that would preclude study
- •No history of allergic reaction to compounds of similar chemical or biologic composition to bortezomib
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior immunotherapy (interferon alfa)
- •Chemotherapy:
- •No more than 1 prior systemic chemotherapy regimen (except hepatic artery chemoembolization)
- •At least 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas)
- •At least 12 weeks since prior hepatic artery chemoembolization (unless liver lesions are not indicator lesions)
- •Stable dose long-acting octreotide therapy (Sandostatin LAR) within the past 3 months allowed
- •Concurrent subcutaneous octreotide for breakthrough symptomatic relief allowed
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- 另有 4 项未显示
排除标准
- 未提供
研究者
研究点 (2)
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