Phase I/II Study Of Herceptin Combined With OSI-774 In The First-Line Treatment Of Metastatic Breast Cancer Associated With HER2/Neu Overexpression
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- The Objective Response Rate as Defined as Stable Disease or the Rate of Complete and Partial Responses Determined on Two Consecutive Occasions Greater Than or Equal to 4 Weeks Apart.
研究概览
简要总结
RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Combining trastuzumab with erlotinib may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with erlotinib as first-line therapy in treating women who have metastatic breast cancer associated with HER2/neu overexpression.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose and recommended phase II dose of erlotinib when combined with trastuzumab (Herceptin) as first-line therapy in women with metastatic breast cancer associated with HER2/neu overexpression. (Phase I closed to accrual as of 01/2004)
- Determine the safety profile of this regimen in these patients.
- Determine the rate and duration of objective response in patients treated with this regimen.
- Determine the pharmacologic behavior of this regimen in these patients.
- Determine time to disease progression and duration of survival in patients treated with this regimen.
- Correlate the antitumor activity of this regimen with epidermal growth factor receptor expression in these patients.
OUTLINE: This is a dose-escalation study of erlotinib. (Phase I closed to accrual as of 01/2004).
Patients receive oral erlotinib once daily beginning on day 2 and trastuzumab (Herceptin) IV over 30-90 minutes (1-4 hours after erlotinib) once weekly beginning on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib 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. Once the MTD is determined, additional patients are treated at the recommended phase II dose.
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
- •Women aged > 18 years
- •Histologically documents metastatic breast cancer
- •HER2 positive using Fluorescence In Situ Hybridization (FISH)
- •For phase I, patients who have previously received treatment for their metastatic disease are allowed to participate.
- •For the phase II portion of the study, patients must have measureable disease (> 2 cm; > 1 cm on spiral CT scan)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- •A life expectancy of > 3 months
- •Use of effective means of contraception
排除标准
- •For Phase II, prior cytotoxic chemotherapy and/or prior Herceptin for their metastatic disease. Prior treatment in the adjuvant setting is allowed.
研究组 & 干预措施
treatment
please see intervention description
干预措施: trastuzumab (Biological)
treatment
please see intervention description
干预措施: erlotinib hydrochloride (Drug)
结局指标
主要结局
The Objective Response Rate as Defined as Stable Disease or the Rate of Complete and Partial Responses Determined on Two Consecutive Occasions Greater Than or Equal to 4 Weeks Apart.
时间窗: 5 years
Complete Response: The disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured. Also called complete remission. Partial Response: A decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment. Also called partial remission.
Recommended Dose for Phase II
时间窗: treatment period
次要结局
- Serum Concentration of Herceptin at Specified Time-points.(4 months)
- Duration of Objective Response(5 years)
- Incidence of Adverse Events(5 years)