NCT00317434终止1 期
A Phase I Trial of Lapatinib in Combination With Carboplatin in Patients With Platinum Sensitive Recurrent Epithelial Ovarian Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- MTD of Lapatinib measured in cohorts of 3-6 patients each
研究概览
简要总结
The purpose of this study is to determine the maximum tolerated dose of Lapatinib with Carboplatin AUC 6 in patients with platinum sensitive recurrent ovarian or primary peritoneal carcinoma and to determine the nature and degree of toxicity of Lapatinib in combination with carboplatin AUC 6 in this cohort of 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
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologic diagnosis of epithelial ovarian or primary peritoneal cancer
- •Measurable disease or evaluable disease with CA125 >100
- •One prior treatment with taxane/platinum based chemotherapy, but patients with recurrent ovarian cancer not receiving platinum-based chemotherapy at time of initial diagnosis will be allowed
- •Recurrence after treatment free interval of at least 6 mos from completion of primary chemotherapy
- •19 years of age or older
- •Life expectancy of greater than 12 weeks
- •Performance status of 0, 1 or 2 (based on GOG Performance Status)
- •Normal bone marrow, renal and hepatic function based upon lab tests
- •Cardiac ejection fraction within institutional normal range
- •Ability to swallow and retain oral medication
- •Ability to understand a written informed consent document
排除标准
- •Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering study
- •Epithelial ovarian tumors of low malignant potential, stromal or germ cell origin
- •Non-measurable or non-evaluable disease
- •Archived tumor tissue not available for assay
- •Patients may not be receiving any other investigational agents or concurrent anticancer therapy, or herbal (alternative) medicines
- •Patients with known brain metastases
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.
- •Uncontrolled inter-current illness
- •Patients who are pregnant
- •HIV-positive patients receiving combination anti-retroviral therapy
- •Patients with GI tract disease resulting in an inability to take oral medication
结局指标
主要结局
MTD of Lapatinib measured in cohorts of 3-6 patients each
次要结局
- Clinical response rate defined by RECIST and CA125 values
- EGRF, ErbB-2, PTEN and K-ras expression in tissue samples
- Correlate serum levels of Lapatinib with AE's & efficacy
研究者
研究点 (4)
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