NCT00263822已完成3 期
A Randomized, Multicenter, Phase III Study of Erlotinib Versus Observation in Patients With no Evidence of Disease Progression After First Line, Platinum-Based Chemotherapy For High-Risk Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
European Organisation for Research and Treatment of Cancer - EORTC92 个研究点 分布在 5 个国家目标入组 835 人开始时间: 2005年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 835
- 试验地点
- 92
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sometimes after treatment, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether erlotinib is more effective than observation after first-line chemotherapy in treating patients with ovarian cancer, peritoneal cancer, or fallopian tube cancer.
PURPOSE: This randomized phase III trial is studying erlotinib to see how well it works compared to observation in treating patients who have undergone first-line chemotherapy for ovarian cancer, peritoneal cancer, or fallopian tube cancer.
详细描述
OBJECTIVES:
Primary
- Compare the benefits, in terms of progression-free survival, of maintenance therapy comprising erlotinib vs observation in patients with responding or stable disease after first-line, platinum-based chemotherapy for high-risk stage I or stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer.
Secondary
- Compare the overall survival of patients treated with these regimens.
- Determine the safety of erlotinib in these patients.
- Compare the quality of life of patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
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 ovarian epithelial, primary peritoneal, or fallopian tube cancer meeting 1 of the following criteria:
- •High-risk stage I disease, as defined by grade 3, aneuploid grade 1 or 2, or clear cell disease
- •Stage II, III, or IV disease
- •Completed first-line therapy within the past 6 weeks
- •Received a platinum derivative (carboplatin or cisplatin) alone or in combination with other agents for 6-9 courses
- •Must have achieved complete response/no evidence of disease, partial response, or stabilization of disease after therapy
- •No adenocarcinoma of unknown origin
- •No known brain metastases or leptomeningeal disease
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Platelet count ≥ 100,000/mm^3
- •WBC ≥ 2,000/mm^3
- •AST and ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN in patients with known liver metastases)
- •Bilirubin ≤ 1.5 times ULN
- •Alkaline phosphatase ≤ 5 times ULN except in patients with known bone metastases
- •PT and PTT ≤ 1.5 times ULN
- •Creatinine ≤ 2 times ULN
- •Cardiovascular
- •No myocardial infarction within past 6 months
- •No second- or third-degree heart block without pacemaker
- •Gastrointestinal
- •No active peptic ulcer disease
- •No gastrointestinal tract disease that would interfere with ability to take oral medications, affect absorption, or require parenteral nutrition
- •No uncontrolled inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No significant dermatologic disease
- •No inflammatory changes to the surface of the eye
- •No history of allergic reaction to compounds of similar chemical composition as erlotinib
- •No other significant medical condition or neurologic or psychiatric disorder
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or cone-biopsied carcinoma in situ of the cervix
- •No psychiatric illness or familial, geographic, or social situation that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior therapy targeting epidermal growth factor receptor
- •No concurrent immunotherapy
- •Chemotherapy
- •See Disease Characteristics
- •See Surgery
- •No concurrent chemotherapy
- •Endocrine therapy
- •No concurrent hormonal therapy
- •Radiotherapy
- •No prior radiotherapy unless completed more than 5 years ago AND outside the abdomen/pelvis
- •Interval debulking surgery after 3 courses of chemotherapy and second-look surgery at the end of chemotherapy allowed as per study EORTC-55971/NCIC OV13/Chorus
- 另有 3 项未显示
排除标准
- 未提供
结局指标
主要结局
Progression-free survival
次要结局
- Overall survival
- Adverse event profile
- Quality of life
- Cutaneous toxicity (rash or acne [papulo-pustular rash])
研究者
研究点 (92)
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