NCT00159094Unknown2 期
A Phase II Trial of Doxil and Multiday Vinorelbine in Patients With Metastatic Breast Cancer
Hematology Oncology Consultants3 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2003年10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
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Response rate
研究概览
简要总结
This is a phase II trial of Doxil on day 1 and vinorelbine on days 1 and 2 in women with metastatic breast cancer. Administered every 28 days. A study to assess the safety and efficacy of Doxil and vinorelbine in metastatic breast cancer.
详细描述
PROTOCOL SUMMARY
Study design: Phase II trial of monthly Doxil® and vinorelbine on day 1 and 2 in women with metastatic breast cancer.
Treatment plan: Patients will continue therapy, until they have unacceptable toxicity or disease progression.
Primary endpoint: Response rate
Secondary endpoints: Time to progression, overall survival and toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patients must be informed of the investigational nature of this study and must give and sign informed consent in compliance with federal and institutional guidelines.
- •Women 18 years or older with biopsy proven advanced breast cancer.
- •Patients with reproductive potential must use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide, or surgical sterilization) during treatment and for three months after completing treatment.
- •Performance status (PS) 0-2 (ECOG). PS must be 0-1 if patient has had more than one prior regimen for metastatic disease or more than 2 prior regimens, including adjuvant and metastatic.
- •Measurable disease by RECIST criteria, with baseline staging completed within 14 days of registration.
- •At least two weeks post surgery and three weeks from completion of irradiation and recovered from toxicities associated with these treatments.
- •Psychological, family, social and geographical conditions allowing weekly medical follow up during chemotherapy are required.
- •Preregistration blood work must include complete blood counts with differential, and blood chemistries including serum bilirubin, GGT, LDH, SGOT, SGPT, alkaline phosphatase, creatinine, and tumor markers, CEA and CA 27-
- •Patients must have:
- •Absolute neutrophil count (ANC) >1,500/mm3
- •Platelet count >100,000/mm3
- •Hemoglobin > 8.0 g/dl
- •Serum creatinine < 2.5 mg/dl (< 200 mol/L)
- •Serum bilirubin < the upper limit of normal (ULN)
- •SGOT and SGPT or AST and ALT < 2.0 x ULN
- •Alkaline phosphatase < 2.0 x ULN, except if attributed to tumor
- •Life expectancy > than 12 week.
排除标准
- •Prior Doxil® or vinorelbine
- •Cumulative anthracycline dose exceeding 400 mg/m2 anthracycline
- •Primary anthracycline refractory disease, ie. disease progression during treatment or relapse/recurrence within 6 months after last dose of anthracycline
- •If PS 0-1, more than 3 prior chemotherapy regimens, including adjuvant and metastatic
- •If PS 2, more than 1 prior regimen for metastatic disease or more than 2 prior chemotherapy regimens, including adjuvant and metastatic
- •Hormone therapy including aromatase inhibitors within 2 weeks of baseline
- •Pregnant or lactating women. Women of reproductive potential must have a negative pregnancy test and must agree to use an effective contraceptive method
- •Prior history of cardiac disease, with New York Heart Association Class II or greater, or clinical evidence of congestive heart failure
- •Symptomatic brain metastasis
- •Past medical history of severe hypersensitivity reaction to conventional formulation of doxorubicin HCL or the components of Doxil® or vinorelbine
结局指标
主要结局
Response rate
次要结局
- Time to progression
- Overall survival
- Toxicity
研究者
研究点 (3)
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