NCT00028483终止2 期
A Phase II Study Using SGN-15 (cBR96 - Doxorubicin Immunoconjugate) in Combination With Taxotere for the Treatment of Metastatic or Recurrent Breast Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Seagen Inc.
- 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. Monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and monoclonal antibody therapy in treating women who have metastatic or recurrent breast cancer.
详细描述
OBJECTIVES:
- Determine the toxicity and safety profile of doxorubicin-monoclonal antibody BR96 immunoconjugate (SGN-15) and docetaxel in women with metastatic or recurrent breast cancer.
- Determine the clinical response rate and duration of response of patients treated with this regimen.
OUTLINE: Patients receive doxorubicin-monoclonal antibody BR96 immunoconjugate (SGN-15) IV over 2 hours and docetaxel IV over 30 minutes on day 1 of weeks 1-6. Treatment repeats every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks.
PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study within 18-24 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
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed metastatic or recurrent breast carcinoma
- •Unresectable disease
- •Previously treated with no more than 2 chemotherapy regimens for metastatic disease OR
- •Recurrent within 6 months of adjuvant chemotherapy
- •Must have one of the following:
- •Measurable disease
- •Positive bone scan and elevation of serum tumor marker for adenocarcinoma
- •Serum levels must have increased over 2 consecutive measurements and exceed at least 2 times upper limit of normal
- •Lewis-y antigen expression documented by immunohistochemistry
- •No brain metastases that are uncontrolled or require active treatment (including steroids)
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status:
- •Not specified
- •Performance status:
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •Hemoglobin at least 10 g/dL
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •No bleeding diathesis
- •Bilirubin no greater than 1.5 mg/dL
- •SGOT no greater than 2.5 times normal
- •Alkaline phosphatase no greater than 2.5 times normal (unless documented bony metastasis present)
- •Amylase/lipase less than 1.5 times normal
- •Hepatitis B and C negative
- •No hepatic failure
- •Creatinine no greater than 1.5 times upper limit of normal
- •No renal failure
- •Cardiovascular:
- •LVEF greater than 50% by echocardiogram or MUGA scan
- •No congestive heart failure
- •HIV negative
- •No antibody present that detects monoclonal antibody BR96 in serum
- •No peripheral neuropathy grade 2 or greater
- •No dementia or altered mental status
- •No other serious underlying medical condition that would preclude study participation
- •No prior allergic reactions to recombinant human or murine proteins
- •No uncontrolled peptic ulcer disease
- •No active viral, bacterial, or systemic fungal infections
- •No other primary malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No serious nonmalignant disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- 另有 16 项未显示
排除标准
- 未提供
研究者
研究点 (2)
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