NCT00074009已完成2 期
A Multicenter, Open-Label, Two-Stage, Phase II Study Of PS-341 (LDP-341, NSC # 681239) In Patients With Unresectable Or Metastatic Gastric Adenocarcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 4
研究概览
简要总结
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of bortezomib in patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
Secondary
- Determine the toxicity of this drug in these patients.
- Determine possible predictors of response to this drug, using pretreatment tumor immunohistochemistry, in these patients.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma
- •Siewert's class II or III disease
- •Measurable disease
- •At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- •No history of known or active brain metastases or primary brain tumors
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 60-100% OR
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count at least 1,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 mg/dL
- •AST and ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- •Creatinine no greater than 1.5 mg/dL
- •Cardiovascular
- •No prior cerebrovascular event
- •No prior orthostatic hypotension
- •No myocardial infarction within the past 6 months
- •No peripheral vascular disease requiring surgical management
- •No evidence of acute ischemia or significant conduction abnormality by EKG
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for at least 2 months after study participation
- •No evidence of peripheral neuropathy
- •No prior allergic reaction attributed to compounds of similar chemical or biological composition to bortezomib
- •No other malignancy within the past 3 years except basal cell skin cancer, carcinoma in situ of the cervix, or adequately treated nonmetastatic prostate cancer
- •No ongoing or active infection
- •No psychiatric illness or social situation that would preclude study participation
- •No other concurrent uncontrolled illness that would preclude study participation
- •No other medical condition or reason that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 3 weeks since prior immunotherapy
- •No concurrent biological or immunological agents
- •Chemotherapy
- •No more than 1 prior chemotherapy regimen (including adjuvant chemotherapy)
- •More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- •No concurrent chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •More than 3 weeks since prior radiotherapy
- •No concurrent radiotherapy
- •Not specified
- •Recovered from all prior therapy
- 另有 2 项未显示
排除标准
- 未提供
研究者
研究点 (4)
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