NCT00054470撤回2 期
A Phase II Evaluation Of The Efficacy And Safety Of R115777 (NSC702818) A Non-Peptidomimetic Farnesyl Transferase Inhibitor, And Trastuzumab In Patients With Advanced Breast Cancer
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试验速览
研究概览
简要总结
RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell 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 tipifarnib with trastuzumab may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining tipifarnib with trastuzumab in treating patients who have metastatic breast cancer.
详细描述
OBJECTIVES:
- Determine the antitumor activity of tipifarnib and trastuzumab (Herceptin) in patients with metastatic breast cancer.
- Determine the safety and tolerability of this regimen in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral tipifarnib twice daily on days 1-21 and trastuzumab (Herceptin) IV over 30-90 minutes on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 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
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed metastatic adenocarcinoma of the breast
- •HER2/neu 3+ by immunohistochemical staining
- •2+ eligible provided HER2/neu positive by fluorescent in-situ hybridization (FISH)
- •HER2/neu positive by FISH alone allowed
- •Unidimensionally measurable disease
- •At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- •Must have received prior trastuzumab (Herceptin)
- •Patients with known brain metastases meeting any of the following criteria are not eligible:
- •Require high-dose steroid therapy or enzyme-inducing anticonvulsant drugs
- •No prior cranial radiotherapy
- •Have progressive neurologic dysfunction that would preclude study evaluation
- •Have evidence of progressive CNS disease by CT scan or MRI
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •Male or female
- •Menopausal status
- •Not specified
- •Performance status
- •ECOG 0-2 OR
- •Karnofsky 70-100%
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 9.0 g/dL
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •AST and ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present)
- •Creatinine no greater than 1.5 times ULN OR
- •Creatinine clearance greater than 60 mL/min
- •Cardiovascular
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Ejection fraction greater than 50% by MUGA or echocardiogram
- •Gastrointestinal
- •No gastrointestinal tract disease resulting in an inability to tolerate oral medication
- •No requirement for IV alimentation
- •No active peptic ulcer disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No significant traumatic injury within the past 21 days
- •No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No ongoing or active infection
- •No prior allergic reaction attributed to compounds of similar chemical or biological composition to tipifarnib (e.g., quinolones) or trastuzumab
- •No psychiatric illness or social situation that would preclude study compliance
- •No other concurrent medical illness that would preclude study compliance
- 另有 29 项未显示
排除标准
- 未提供
研究者
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