NCT00888810终止2 期
A Phase II Study Evaluating the Association of Topotecan and Lapatinib in Early Recurrent (Less Than 12 Months)Ovarian or Peritoneal Cancer Patients After First Line of Platinum-Based Chemotherapy
Centre Francois Baclesse42 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2008年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 39
- 试验地点
- 42
- 主要终点
- Evaluation of global response rate (complete response, partial response and stable disease)of the association topotecan-lapatinib.
研究概览
简要总结
The objective of the trial was to evaluate the efficacy of the association of topotecan and lapatinib in patients who failed first line platinum-based chemotherapy within 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Age superior or equal 18 years
- •primitive ovarian adenocarcinoma histologically confirmed
- •or peritoneal or fallopian tube adenocarcinoma histologically confirmed
- •Progression or relapse within 12 months after the end of first line of platin based chemotherapy
- •association in first line with other anticancer agent is allowed (taxanes, anthracyclines, alkylants or gemcitabine) and with an anti-angiogenic (bevacizumab, sunitinib).
- •intra-peritoneal chemotherapy in first line is possible
- •No previous treatment with HER inhibitors (ex : gefitinib)
- •HER status not necessary
- •measurable lesions (RECIST criteria). and/or CA125 value higher than 2 fold the normal value or CA125 higher than 2 fold nadir value (if no normalized) proved by two samples distant of 1 month
- •OMS inferior or equal
- •biological parameters as follow: creatininemia ≤ 150 µmol/L or clearance ≥ 50 mL/min,bilirubin ≤ 1,5 LNS,transaminases and or alcalin phosphatases ≤ 2 LNS without hepatic metastasis or ≤ 3 LNS if hepatic metastasis,neutrophils ≥ 1,5.109/L,plaquettes ≥ 100.109/L.
- •normal FEV
- •No previous treatment by chemotherapy, hormonotherapy, immunotherapy or radiotherapy within 4 weeks before inclusion
- •No concomitant treatment forbidden with lapatinib.
- •No previous treatment by Amiodarone in 6 months before inclusion
- •signed informed consent
排除标准
- •Previous treatment with :
- •intensive chemotherapy with autograft
- •two lignes of chemotherapy
- •previous total abdominal irradiation
- •previous chemotherapy with anti-HER treatment
- •History of brain or meningitis metastasis uncontrolled.
- •Malignancies except for adequately treated carcinoma in situ of the cervix and/or basal cell skin cancer.
- •uncontrolled infectious pathology
- •uncontrolled cardiovascular disease
- •Patients with an active intestinal occlusion not permit oral treatment
- •known hypersensibility to topotecan and its excipients
- •Woman of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period
- •Individual deprived of liberty
结局指标
主要结局
Evaluation of global response rate (complete response, partial response and stable disease)of the association topotecan-lapatinib.
时间窗: every two cycles of chemotherapy
次要结局
- Global survival rate, survival rate without progression, response time, time without progression, safety, quality of life, Caracterisation of biological response (tumor, ascite and blood samples)(each cycle of chemotherapy)
研究者
研究点 (42)
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