A Phase II Trial of Lapatinib in Combination With Weekly Topotecan in Patients With Platinum-Refractory/Resistant Ovarian and Primary Peritoneal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 18
- 试验地点
- 3
- 主要终点
- Response Rate (Complete Response (CR) or Partial Response (PR))
研究概览
简要总结
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Giving lapatinib together with topotecan may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving lapatinib together with topotecan works in treating patients with ovarian epithelial cancer or primary peritoneal cancer that did not respond to cisplatin or carboplatin.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of lapatinib ditosylate and topotecan hydrochloride, in terms of response, in patients with platinum-resistant or refractory ovarian epithelial or primary peritoneal cavity carcinoma.
Secondary
- Determine the overall survival time in patients treated with this regimen.
- Determine the time to progression in patients treated with this regimen.
- Assess the toxicity profile of this regimen in these patients.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lapatinib + Topotecan
Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
干预措施: Lapatinib (Drug)
Lapatinib + Topotecan
Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
干预措施: Topotecan (Drug)
结局指标
主要结局
Response Rate (Complete Response (CR) or Partial Response (PR))
时间窗: Two consecutive evaluations at least 4 weeks apart
Measurable disease patients: measureable disease is defined as at least one lesion whose longest diameter \>= 2cm with conventional techniques or \>=1cm with spiral CT * Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 4 weeks apart. * Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions. Non-measurable disease patients: * Decrement in CA125 by \> 50% * Improvement in other evaluable disease
次要结局
- Time to Progression(Time from registration to progression (up to 2 years))
- Adverse Event Profile(Every 4 weeks)
- Overall Survival(Time from Registration to Death or last follow-up (up to 3 years))