A Phase II Study Of PS-341 In Metastatic Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Overall response rate to PS-341 therapy
研究概览
简要总结
Phase II trial to study the effectiveness of bortezomib in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer. Bortezomib may interfere with the growth of tumor cells by blocking certain enzymes necessary for tumor cell growth
详细描述
PRIMARY OBJECTIVES:
I. Determine the response rate, time to progression, and survival of patients with advanced non-small cell lung cancer treated with bortezomib.
II. Determine the toxicity of this drug in these patients. III. Correlate toxicity and activity of this drug with markers of proteasome inhibition in blood and peripheral mononuclear cells in these patients.
OUTLINE:
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who received prior bortezomib and achieved at least a partial response of at least 6 months duration may also receive therapy as above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Histologically or cytologically confirmed non-small cell lung cancer
- •Mixed tumors allowed unless small cell elements are present
- •Stage IIIB or IV or recurrent disease
- •At least 1 measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- •No known brain metastases
- •Performance status - ECOG 0-1
- •More than 3 months
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ 2 mg/dL
- •AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver involvement present)
- •Creatinine ≤ 2 mg/dL
- •Creatinine clearance ≥ 60 mL/min
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No peripheral neuropathy > grade 1
- •No other concurrent uncontrolled illness
- •No ongoing or active infection
- •No psychiatric illness or social situation that would preclude study participation
- •No more than 1 prior chemotherapy regimen
- •Two prior chemotherapy regimens allowed provided 1 of the 2 regimens was gefitinib monotherapy as second-line therapy
- •At least 4 weeks since prior chemotherapy (6 weeks for carmustine, mitomycin, or nitrosoureas) and recovered
- •At least 4 weeks since prior radiotherapy (except localized radiotherapy for symptom relief) and recovered
- •Prior bortezomib allowed provided patient achieved at least a partial response (of at least 6 months duration), received no other therapy since the last dose of bortezomib, and has no residual toxicity greater than grade 1
- •No other concurrent investigational or commercial agents or therapies for malignancy
排除标准
- 未提供
研究组 & 干预措施
Treatment (bortezomib)
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who received prior bortezomib and achieved at least a partial response of at least 6 months duration may also receive therapy as above.
干预措施: bortezomib (Drug)
结局指标
主要结局
Overall response rate to PS-341 therapy
时间窗: Up to 4 years
次要结局
- Progression-free survival(Up to 4 months)
- Overall survival(Up to 4 hours)