NCT00027989Unknown2 期
An Open-Label, Single-Arm, Phase II Study of Liposomal Doxorubicin (Doxil) and Gemcitabine in the Treatment of Women With Metastatic Breast Cancer
Pharmatech Oncology11 个研究点 分布在 1 个国家开始时间: 2001年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 11
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 combining liposomal doxorubicin with gemcitabine in treating women who have metastatic breast cancer.
详细描述
OBJECTIVES:
- Determine the objective response rate in women with metastatic breast cancer treated with doxorubicin HCl liposome and gemcitabine.
- Determine the duration of response, time to disease progression, and duration of survival of patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Determine the quantitative toxicity of this regimen, in terms of incidence, type, and severity, in these patients.
OUTLINE: This is a multicenter study.
Patients receive doxorubicin HCl liposome IV over 1 hour on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 courses beyond documentation of CR.
Quality of life is assessed at baseline, on day 1 of each course, and then at the end of study.
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 or cytologically confirmed metastatic breast cancer
- •Measurable disease
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status:
- •Not specified
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 9 g/dL
- •Absolute neutrophil count at least 1,500/mm^3
- •No impaired bone marrow function
- •Bilirubin no greater than 2 mg/dL
- •AST and ALT no greater than 2 times upper limit of normal (ULN)
- •Alkaline phosphatase no greater than 2 times ULN (unless attributed to tumor)
- •No impaired hepatic function
- •Creatinine no greater than 2.5 mg/dL OR
- •Creatinine clearance at least 60 mL/min
- •No impaired renal function
- •Cardiovascular:
- •No prior cardiac disease within the past 5 years OR
- •LVEF at least 50%
- •No prior uncontrolled seizures
- •No uncontrolled systemic infection
- •No anthracycline resistance
- •No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior trastuzumab (Herceptin)
- •Chemotherapy:
- •Prior adjuvant therapy with anthracycline of no more than 320 mg/m^2 allowed
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior radiotherapy to more than 1/3 of hematopoietic sites
- •Not specified
- •At least 30 days since prior investigational medications and recovered
- •No more than 1 prior treatment regimen for metastatic disease
排除标准
- 未提供
研究者
研究点 (11)
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