NCT00003540已完成2 期
Phase II Study of Gemcitabine in the Treatment of Patients With Metastatic Breast Cancer Previously Treated With Adriamycin and Taxol
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 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.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating women with metastatic breast cancer previously treated with doxorubicin and paclitaxel.
详细描述
OBJECTIVES:
- Determine the objective response rate to gemcitabine in women with metastatic breast cancer previously treated with two to four chemotherapy regimens, including doxorubicin and paclitaxel.
- Characterize the nature of toxicity of gemcitabine in this patient population.
- Determine the response duration to gemcitabine in this patient population.
OUTLINE: Patients receive gemcitabine IV over 30 minutes once weekly for 3 consecutive weeks (days 1, 8, and 15) followed by 1 week of rest. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxic effects.
Patients are followed until death.
PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 13 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 breast cancer
- •Bidimensionally measurable disease
- •No bone scan abnormalities alone
- •Lytic lesions in conjunction with bone scan abnormalities allowed
- •No pure blastic bone metastases
- •No pleural or peritoneal effusions
- •No previously irradiated lesions
- •Must have received 2-4 prior chemotherapy regimens, including paclitaxel and doxorubicin, for breast cancer
- •Brain metastases allowed if other measurable disease exists
- •No uncontrolled or life threatening brain lesions
- •No carcinomatous meningitis
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status:
- •Not specified
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •AST/ALT no greater than 5 times upper limit of normal
- •Calcium no greater than 11.0 mg/dL
- •Not pregnant
- •Negative pregnancy test
- •No history of other malignancy except carcinoma in situ of the cervix or curatively treated nonmelanoma skin cancer
- •No other serious medical illnesses, including severe infection and severe malnutrition
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •Prior hormonal therapies for stage IV disease and/or adjuvant therapy allowed
- •At least 3 weeks since prior hormonal therapy
- •Radiotherapy:
- •See Disease Characteristics
- •No prior radiotherapy to greater than 30% of the marrow bearing bone
- •At least 4 weeks since prior radiotherapy and recovered
- •No concurrent radiotherapy to the only measurable lesion
- •Recovered from prior surgery
- •No concurrent surgery to the only measurable lesion
- •No concurrent nonprotocol treatment
排除标准
- 未提供
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Gemcitabine in Treating Children With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous LeukemiaLeukemiaNCT00006462Children's Oncology Group32
已完成
2 期
Gemcitabine in Treating Patients With Recurrent or Metastatic Adenoid Cystic Cancer of the Head and NeckHead and Neck CancerNCT00017498European Organisation for Research and Treatment of Cancer - EORTC21
已完成
2 期
Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic CancerPancreatic CancerNCT00049348Eastern Cooperative Oncology Group
已完成
2 期
Gemcitabine Plus Radiation Therapy in Treating Patients With Pancreatic CancerPancreatic CancerNCT00003546Alliance for Clinical Trials in Oncology43
已完成
2 期
S0119: Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung CancerLung CancerNCT00030433SWOG Cancer Research Network85