A Phase II Study Of OSI-774 (NSC 718781) Given In Combination With Carboplatin In Patients With Recurrent Epithelial Ovarian Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 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. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with carboplatin may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining erlotinib and carboplatin in treating patients who have recurrent ovarian, fallopian tube, or primary peritoneal cancer.
详细描述
OBJECTIVES:
- Determine the response rate in patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer treated with erlotinib and carboplatin.
- Determine the duration of stable disease, time to progression, and response duration in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Correlate the level of epidermal growth factor receptor tumor expression with objective tumor response in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to response to prior platinum-containing therapy (platinum-sensitive, defined as 6 months or more since prior therapy with platinum agent [closed to accrual as of 2/13/2004], vs platinum-resistant, defined as less than 6 months since prior therapy with platinum agent).
Patients receive carboplatin IV over 30 minutes on day 1 and oral erlotinib once daily on days 1-21. Treatment repeats every 21 days for up to 6 courses. After the completion of 6 courses of therapy, patients with responsive or stable disease may continue to receive erlotinib and carboplatin in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks and then every 3 months thereafter.
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 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer for which no standard curative therapy exists
- •At least 1 measurable lesion
- •At least 20 mm by x-ray, non-spiral CT scan, or physical exam OR at least 10 mm by spiral CT scan
- •Ascites and bone metastases not considered measurable disease
- •No abdominal adenocarcinoma of unknown origin or borderline ovarian tumor
- •No elevated CA 125 as only evidence of disease
- •At least 1 but no more than 2 prior chemotherapy regimens required
- •First regimen must have contained cisplatin or carboplatin
- •Switching platinum compounds due to disease progression or failure to respond is considered 2 regimens
- •Same regimen as first- and second-line therapy is considered 2 regimens
- •Responded to prior platinum-based first-line chemotherapy
- •No platinum-refractory disease
- •No known brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •Absolute granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than upper limit of normal (ULN)
- •AST/ALT no greater than 2.5 times ULN
- •Creatinine no greater than ULN
- •Cardiovascular:
- •No symptomatic congestive heart failure
- •No unstable angina
- •No cardiac arrhythmia
- •Gastrointestinal:
- •See Surgery
- •No GI tract disease resulting in an inability to take oral medication or requiring IV alimentation
- •No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
- •No active peptic ulcer disease
- •Ophthalmic:
- •No ocular inflammation or infection
- •No significant ophthalmologic abnormalities, including:
- •History of dry eye syndrome, Sjögren's syndrome, or keratoconjunctivitis sicca
- •Severe exposure keratopathy
- •Disorders that might increase the risk for 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)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No prior allergic reaction to compounds of similar chemical or biological composition to erlotinib
- •No other serious illness, medical condition, or significant neurologic or psychiatric disorder that would preclude study therapy
- •No active uncontrolled infection
- •No grade 3 or greater drug-related neurotoxicity
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排除标准
- 未提供