NCT00005861已完成2 期
Evaluation of Doxil as First-Line Therapy of Advanced or Recurrent Endometrial Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 10
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 liposomal doxorubicin in treating women who have recurrent, stage III, or stage IV endometrial cancer.
详细描述
OBJECTIVES:
- Determine the antitumor activity and safety of doxorubicin HCl liposome in patients with advanced or recurrent endometrial cancer.
- Determine the response rate, response duration, and overall survival of these patients treated with this regimen.
OUTLINE: Patients receive doxorubicin HCl liposome IV over 1 hour. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed stage III, IV, or recurrent endometrial carcinoma for which curative radiotherapy or surgery is not an option
- •Bidimensionally measurable disease
- •Irradiated field as only site allowed if evidence of progression since radiotherapy
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •SGOT no greater than 3 times ULN
- •Alkaline phosphatase no greater than 3 times ULN
- •Creatinine no greater than 1.5 times ULN
- •Cardiovascular:
- •LVEF normal by cardiac echocardiogram or MUGA
- •No concurrent active infection
- •No prior or concurrent malignancy within past 5 years except nonmelanoma skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Prior chemotherapy as radiosensitizer allowed
- •No prior chemotherapy for advanced or metastatic disease
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •Recovered from prior radiotherapy
- •See Disease Characteristics
- •Recovered from prior surgery
- •No prior therapy that would preclude study
- •No other concurrent antineoplastic agents
- •No other concurrent investigational agents
排除标准
- 未提供
研究者
研究点 (10)
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