NCT00068757已完成1 期
Phase I Study of Lonafarnib (SCH66336) in Combination With Herceptin Plus Paclitaxel in HER 2 NEU Overexpressing Breast Cancer
European Organisation for Research and Treatment of Cancer - EORTC3 个研究点 分布在 3 个国家目标入组 23 人开始时间: 2003年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 3
- 主要终点
- Dose-limiting toxicity and maximum tolerated dose as measured by CTC v 2.0
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Lonafarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining lonafarnib and trastuzumab with paclitaxel may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of lonafarnib when given together with trastuzumab and paclitaxel in treating patients with HER2/neu-overexpressing stage IIIB, stage IIIC, or stage IV breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and recommended phase II dose of lonafarnib in combination with trastuzumab (Herceptin®) and paclitaxel in patients with HER2/neu-overexpressing stage IIIB, IIIC, or IV breast cancer.
- Determine the qualitative and quantitative toxicity of this regimen in these patients.
Secondary
- Determine the pharmacokinetic profiles of these drugs in these patients.
- Correlate the pharmacodynamics with the pharmacokinetics of this regimen in these patients.
- Correlate the pharmacokinetics and pharmacodynamics of this regimen with observed toxicity in these patients.
- Determine the response to this regimen in patients with measurable disease.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed breast cancer
- •Stage IIIB, IIIC, or IV
- •HER2/neu overexpression
- •3+ by immunohistochemistry
- •2+ allowed if positive fluorescent in situ hybridization
- •Disease meets the following treatment criteria:
- •Paclitaxel/trastuzumab (Herceptin®) may be appropriate therapy
- •Anthracycline therapy is not a suitable approach
- •No clinical signs of CNS involvement
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Male or female
- •Menopausal status
- •Not specified
- •Performance status
- •ECOG 0-2 OR
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10.0 g/dL (6.2 mmol/L)
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •Alkaline phosphatase less than 2.5 times ULN (5 times ULN if liver metastases are present)
- •AST and ALT less than 2.5 times ULN (5 times ULN if liver metastases are present)
- •Creatinine clearance at least 40 mL/min
- •Cardiovascular
- •Cardiac ejection fraction normal by MUGA
- •QTc interval no greater than 440 msec
- •No cardiac dysfunction
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for up to 3 months after study participation
- •No concurrent severe/unstable systemic disease
- •No infection
- •No circumstances that would preclude study participation (e.g., alcoholism or substance abuse)
- •No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 1 year since prior trastuzumab
- •No concurrent prophylactic growth factors
- •Chemotherapy
- •More than 1 year since prior paclitaxel
- •More than 4 weeks since other prior chemotherapy
- •Endocrine therapy
- •More than 1 day since prior hormonal therapy
- •More than 2 days since prior high-dose chronic steroids
- 另有 19 项未显示
排除标准
- 未提供
结局指标
主要结局
Dose-limiting toxicity and maximum tolerated dose as measured by CTC v 2.0
次要结局
- Translational research
- Pharmacokinetics (PK) and pharmacodynamics (PD)
- Clinical response as measured by RECIST criteria
研究者
研究点 (3)
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