Phase II Trial Of PS-341 In Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Objective tumor response (CR + PR)
研究概览
简要总结
PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. Phase II trial to study the effectiveness of PS-341 in treating women who have metastatic breast cancer
详细描述
PRIMARY OBJECTIVES:
I. Determine the efficacy of PS-341, in terms of response rate, in women with metastatic breast cancer.
SECONDARY OBJECTIVES:
I. Determine the clinical activity of this drug, in terms of progression-free survival, in these women.
II. Determine the toxicity profile and tolerability of this drug in these women.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed invasive breast cancer
- •Clinical and/or radiological evidence of stage IV disease
- •Relapsed or resistant disease within 6-12 months after completion of prior chemotherapy with doxorubicin or epirubicin and/or paclitaxel or docetaxel foradvanced disease or in the adjuvant setting
- •At least 1 unidimensionally measurable lesion
- •At least 20 mm by conventional techniques
- •At least 10 mm by spiral CT scan
- •No bone metastases as only measurable site
- •Pleural or peritoneal effusions not acceptable as measurable disease
- •No known brain metastases
- •Hormone receptor status:
- •Estrogen receptor-negative
- •Estrogen receptor-positive
- •Performance status - ECOG 0-2
- •Performance status - Karnofsky 60-100%
- •More than 12 weeks
- •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 or ALT no greater than 2.5 times upper limit of normal
- •Creatinine normal
- •Creatinine clearance at least 60 mL/min
- •No acute ischemia or significant conduction abnormality by EKG
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •LVEF greater than 50%
- •No uncontrolled concurrent illness
- •No psychiatric illness or social situation that would preclude study
- •No ongoing or active infection
- •No prior allergic reaction(s) to compounds of similar chemical or biologic composition to PS-341
- •No other malignancy within the past 5 years except carcinoma in situ of the cervix or basal cell skin cancer
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier-method contraception
- •See Chemotherapy
- •See Disease Characteristics
- •No more than 1 prior chemotherapy regimen for metastatic disease
- •High-dose regimen or bone marrow transplantation considered 1 prior regimen
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- •Prior hormonal therapy for metastatic disease or in adjuvant setting allowed
- •Prior localized radiotherapy allowed if it does not influence the signal evaluable lesion
- •At least 4 weeks since prior radiotherapy and recovered
- •At least 2 weeks since prior minor surgery and recovered
- •At least 4 weeks since prior major surgery and recovered
- •No other concurrent investigational agent
- •No other concurrent investigational or commercial agents or therapies to treat this malignancy
排除标准
- 未提供
研究组 & 干预措施
Treatment (bortezomib)
Patients receive PS-341 IV over 3-5 seconds twice weekly on weeks 1 and 2. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: bortezomib (Drug)
Treatment (bortezomib)
Patients receive PS-341 IV over 3-5 seconds twice weekly on weeks 1 and 2. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Objective tumor response (CR + PR)
时间窗: Up to 24 months
The agent would be of definite interest for further investigation if the associated response rate is at least 30% (p1), and would not be of further interest if the response rate is below 10% (p0).
次要结局
- Time to progression(Up to 3 years)
- Overall survival(Up to 3 years)
- Correlation between variations in the serum levels of adhesion molecules and angiogenic factors(Up to 24 months)
- Tissue markers of biological activity(Up to 24 months)