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临床试验/NCT00614978
NCT00614978已完成1 期

Phase 1 Study of the Combination of Lapatinib and Temozolomide for the Treatment of Progressive Brain Disease in HER-2 Positive Breast Cancer

Jules Bordet Institute1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2008年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
18
试验地点
1
主要终点
Primary - Determine the maximum tolerated dose (MTD) and evaluate the dose limiting toxicities (DLT) of combining lapatinib and temozolomide

研究概览

简要总结

Objectives:

Primary - Determine the maximum tolerated dose (MTD) and evaluate the dose limiting toxicities (DLT) of combining lapatinib and temozolomideSecondary - Obtain preliminary information on the clinical anti-tumor activity of lapatinib plus temozolomide on brain metastases secondary to HER-2 positive breast cancer including Objective Response Rate (ORR), Clinical Benefit (CB) and Duration of Response (DR)

Methodology:

Phase I, single-centre, open-label, dose-escalation study of combining lapatinib and temozolomide in HER-2 positive breast cancer patients with progressive brain metastases after surgery or radiotherapy or radiosurgery

Treatment:

Temozolomide will be given orally for 5 days of every 28 days, at doses of either 100mg/m2/day or 150mg/m2/day or 200mg/m2/day AND Lapatinib will be given orally every day at either 1000mg/day or 1250mg/day or 1500mg/day.Sequential cohorts will be escalated in increments according to the dose escalation scheme, and determined by dose limiting toxicities.

详细描述

Patients selection criteria:

  • age 18 - 70 years
  • Women with cytologically or histologically proven metastatic breast cancer with recurrent / progressive brain metastases evaluable by MRI, after standard treatment with surgery (at least 3 weeks prior) or WBRT (at least 3 weeks prior) or stereotactic RT (at least 1 week prior); or otherwise deemed as unsuitable for standard treatment in the first instance
  • Known HER-2 positive status (immunohistochemistry (IHC) 3+ Fluorescence In Situ Hybridization (FISH) positive )
  • Previous chemotherapy (adjuvant and metastatic regimens) allowed
  • Previous treatment with trastuzumab allowed (Trastuzumab to be discontinued prior to study entry)
  • At least one measurable lesion in the brain, defined as any lesion >5mm in longest dimension on T1-weighted, gadolinium-enhanced MRI
  • Expected life-expectancy of more than 3 months
  • ECOG performance status of 0, 1 or 2
  • Adequate bone marrow, renal and hepatic functionsLVEF
  • LVEF 50% measured by echocardiography or MUGA scan
  • Concomitant corticosteroids and anti-convulsants for symptomatic brain metastases are allowed

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 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 18 - 70 years
  • Women with cytologically or histologically proven metastatic breast cancer with recurrent / progressive brain metastases evaluable by MRI, after standard treatment with surgery (at least 3 weeks prior) or WBRT (at least 3 weeks prior) or stereotactic RT (at least 1 week prior); or otherwise deemed as unsuitable for standard treatment in the first instance
  • Known HER-2 positive status (immunohistochemistry (IHC) 3+ Fluorescence In Situ Hybridization (FISH) positive )
  • Previous chemotherapy (adjuvant and metastatic regimens) allowed
  • Previous treatment with trastuzumab allowed (Trastuzumab to be discontinued prior to study entry)
  • At least one measurable lesion in the brain, defined as any lesion >5mm in longest dimension on T1-weighted, gadolinium-enhanced MRI
  • Expected life-expectancy of more than 3 months
  • ECOG performance status of 0, 1 or 2
  • Adequate bone marrow, renal and hepatic functionsLVEF
  • LVEF >50% measured by echocardiography or MUGA scan
  • Concomitant corticosteroids and anti-convulsants for symptomatic brain metastases are allowed

排除标准

  • 未提供

研究组 & 干预措施

I

Experimental

Lapatinib plus temozolomide

干预措施: lapatinib and temozolomide (Drug)

结局指标

主要结局

Primary - Determine the maximum tolerated dose (MTD) and evaluate the dose limiting toxicities (DLT) of combining lapatinib and temozolomide

时间窗: 18 months

次要结局

  • Obtain preliminary information on the clinical anti-tumor activity of lapatinib plus temozolomide on brain metastases secondary to HER-2 positive breast cancer including Objective Response Rate, Clinical Benefit and Duration of Response(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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