NCT00030537已完成2 期
A Pilot Study to Evaluate Epidermal Growth Factor Receptor Signaling After Treatment With Oral OSI-774 in Patients With Locally Advanced or Metastatic Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor.
PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have locally advanced or metastatic breast cancer.
详细描述
OBJECTIVES:
- Determine whether a change in epidermal growth factor receptor (EGFR) phosphorylation is detected in tumors of patients with locally advanced or metastatic breast cancer treated with erlotinib.
- Determine whether a change in other parameters of signal transduction that are downstream of EGFR (ERK and AKT) is detected in tumors of patients treated with this drug.
- Determine the toxicity of this drug in these patients.
- Determine the response duration and time to progression in patients treated with this drug.
- Correlate EGFR phosphorylation level with clinical findings and time to progression in patients treated with this drug.
- Correlate the pharmacokinetics of this drug with a change in EGFR phosphorylation in tumor biopsies of these patients.
OUTLINE: Patients receive oral erlotinib once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed within 4 weeks.
PROJECTED ACCRUAL: A total of 15-20 patients will be accrued for this study within 7-10 months.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 confirmed adenocarcinoma of the breast
- •Locally advanced or metastatic disease
- •Incurable disease
- •Tumor accessible for biopsy
- •Prior breast cancer allowed
- •No symptomatic or untreated brain metastases or carcinomatous meningitis
- •Neurologically stable patients with inactive brain metastases are allowed if off corticosteroids for at least 4 weeks prior to study
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Male or female
- •Menopausal status:
- •Not specified
- •Performance status:
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •Granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin normal
- •ALT/AST no greater than 2.5 times upper limit of normal
- •Creatinine normal OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •LVEF at least 40%
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Ophthalmic:
- •No prior abnormalities of the cornea, including:
- •Dry eye syndrome or Sjogren's syndrome
- •Congenital abnormality (e.g., Fuch's dystrophy)
- •Abnormal slit-lamp examination with a vital dye (e.g., fluorescein or Bengal-Rose)
- •Abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test)
- •No concurrent use of contact lenses
- •No prior allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib (e.g., gefitinib or other anilinoquinazolines)
- •No other concurrent uncontrolled illness
- •No active infection
- •No uncontrolled diabetes mellitus
- •No psychiatric illness or social situation that would preclude study
- •No untreated life-threatening disease
- •No other primary malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
- •Weight less than 136 kg
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- 另有 13 项未显示
排除标准
- 未提供
研究者
研究点 (2)
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