Phase II Study of Weekly Paclitaxel and Gemcitabine in Platinum-Resistant Ovarian Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of dexamethasone plus paclitaxel and gemcitabine in treating patients with platinum-resistant recurrent ovarian cancer.
详细描述
OBJECTIVES:
- Determine the response rate, progression time, and survival of patients with platinum-resistant ovarian cancer treated with weekly paclitaxel and gemcitabine.
- Determine the toxic effects of this regimen in these patients.
- Evaluate the toxic effects and safety profile of premedication with steroids with this regimen in these patients.
OUTLINE: Patients are stratified according to prior treatment with paclitaxel (none or relapse more than 6 months after paclitaxel versus progressive disease or relapse less than 6 months after paclitaxel).
Patients receive dexamethasone IV, then paclitaxel IV followed by gemcitabine IV, for 3 consecutive weeks on days 1, 8, and 15. Treatment is continued every 4 weeks in the absence of disease progression or unacceptable toxicity.
All patients are followed until death.
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 recurrent ovarian epithelial cancer
- •Platinum resistant disease defined as:
- •Progression during the most recent platinum-based chemotherapy OR
- •Relapse less than 6 months after platinum-based chemotherapy
- •Measurable or evaluable disease
- •Elevated CA-125 only allowed
- •Positive cytology only not eligible
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Hematopoietic:
- •Granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin less than 2 times upper limit of normal (ULN)
- •AST less than 3 times ULN
- •Creatinine no greater than 2 mg/dL
- •Neurologic:
- •No peripheral neuropathy greater than grade 2
- •No other serious medical illness or psychiatric conditions.
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent hematopoietic growth factors
- •Chemotherapy:
- •See Disease Characteristics
- •No prior gemcitabine
- •No prior paclitaxel administered weekly
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •Not specified
- •Recovered from acute toxic effects secondary to prior therapy
排除标准
- 未提供