NCT00030485已完成2 期
A Phase II Study of OSI-774 (NSC 718781) in Patients With Locally Advanced and/or Metastatic Carcinoma of the Endometrium
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 8
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 determine the effectiveness of erlotinib in treating patients who have locally advanced and/or metastatic endometrial cancer.
详细描述
OBJECTIVES:
- Determine the efficacy of erlotinib, in terms of response rate and duration of stable disease, in patients with locally advanced and/or metastatic carcinoma of the endometrium.
- Determine the toxicity of this drug in these patients.
- Determine the time to progression and duration of response in patients treated with this drug.
- Correlate objective tumor response with levels of epidermal growth factor receptor expression in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks. Patients with complete or partial response or stable disease are also followed every 3 months until relapse or death.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed metastatic and/or locally advanced adenocarcinoma or adenosquamous carcinoma of the endometrium
- •Incurable by standard therapies
- •Clinically and/or radiologically documented disease with at least 1 unidimensionally measurable site
- •At least 20 mm by x-ray, physical exam, or CT scan OR
- •At least 10 mm by spiral CT scan
- •Bone metastases considered nonmeasurable
- •Tumor tissue from primary tumor available for assessing epidermal growth factor receptor (EGFR) status
- •No uterine sarcomas (leiomyosarcoma), mixed mullerian tumors, and/or adenosarcomas
- •No known brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •Platelet count at least 100,000/mm3
- •Absolute granulocyte count at least 1,500/mm3
- •Bilirubin no greater than upper limit of normal (ULN)
- •AST/ALT no greater than 2.5 times ULN
- •Creatinine no greater than 1.5 times ULN
- •Cardiovascular:
- •No symptomatic congestive heart failure
- •No unstable angina
- •No cardiac arrhythmia
- •Gastrointestinal:
- •No gastrointestinal (GI) tract disease that would preclude ability to take oral medication
- •No requirement for IV alimentation
- •No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
- •No active peptic ulcer disease
- •Ophthalmic:
- •No significant ophthalmologic abnormalities, including any of the following:
- •Prior severe dry eye syndrome, Sjogren's syndrome, or keratoconjunctivitis sicca
- •Severe-exposure keratopathy
- •Disorders that would increase the risk of epithelium-related complications (e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis)
- •Congenital abnormality (e.g., Fuch's dystrophy)
- •Abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
- •Abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test)
- •No concurrent ocular inflammation or infection
- •No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix
- •No prior allergic reaction attributed to compounds of similar biological or chemical composition to erlotinib
- •No other concurrent serious illness or medical condition that would preclude study
- •No prior significant neurologic or psychiatric disorder that would preclude study
- •No active uncontrolled infection
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- 另有 15 项未显示
排除标准
- 未提供
研究者
研究点 (8)
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