Phase I Study of Weekly Topotecan in Women With Progressive or Recurrent Ovarian Cancer and a Poor Performance Status
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemotherapy drugs may have different effects in patients who have a poor performance status.
PURPOSE: This phase I trial is studying the side effects and best dose of topotecan in treating patients with progressive or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer with a poor performance status.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of weekly topotecan in patients with progressive or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer and a poor performance status.
Secondary
- Estimate the response rate of women with poor performance status for use in future clinical trials.
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
- •Histological diagnosis of ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer
- •Progressive or recurrent disease
- •Received ≥ 1 prior course of chemotherapy
- •Measurable or evaluable disease OR disease assessable by CA 125, defined as CA 125 > normal that has increased over 2 readings > 14 days apart
- •Karnofsky performance status 10-50%
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Creatinine ≤ 1.5 mg/dL
- •Alkaline phosphatase ≤ 3 times upper limit of normal (ULN)
- •Total bilirubin ≤ 1.5 times ULN
- •SGOT ≤ 3 times ULN
- •Life expectancy ≥ 12 weeks
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use accepted and effective non-hormonal contraception
排除标准
- •Other neoplasm within the past 5 years except for nonmetastatic, nonmelanoma skin cancers, carcinoma in situ of the cervix, or cancer cured by surgery or chemotherapy
- •Septicemia, severe infection, or acute hepatitis
- •Severe gastrointestinal bleeding, defined as requiring a blood transfusion or hospitalization
研究组 & 干预措施
Escalating Cohorts
Patients receive topotecan intravenously (IV) over 30 minutes on days 1, 8, 15, 22, and 29. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A total of 6 patients will be treated at the MTD.
干预措施: topotecan hydrochloride (Drug)
结局指标
主要结局
Maximum tolerated dose
次要结局
未报告次要终点