NCT00483782已完成3 期
ICON7 - A Randomised, Two-Arm, Multi-Centre Gynaecologic Cancer InterGroup Trial of Adding Bevacizumab to Standard Chemotherapy (Carboplatin and Paclitaxel) in Patients With Epithelial Ovarian Cancer
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,520
- 试验地点
- 142
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving carboplatin and paclitaxel together with bevacizumab is more effective than carboplatin and paclitaxel alone in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.
PURPOSE: This randomized phase III trial is studying carboplatin, paclitaxel, and bevacizumab to see how well they work compared with carboplatin and paclitaxel alone in treating patients with newly diagnosed ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.
详细描述
OBJECTIVES:
Primary
- Compare the progression-free survival and overall survival of patients with newly diagnosed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer treated with carboplatin and paclitaxel with vs without bevacizumab.
Secondary
- Compare the response rate in patients treated with these regimens.
- Compare the duration of tumor response in patients treated with these regimens.
- Compare the biological progression-free interval, as measured by increasing CA 125 levels, in patients treated with these regimens.
- Compare the safety (e.g., adverse events, laboratory results, and performance status) of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
- Compare the cost-effectiveness of these regimens in these patients.
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, fallopian tube, or primary peritoneal cavity cancer
- •Newly diagnosed disease
- •Meets 1 of the following staging criteria:
- •High-risk stage I or IIA disease (grade 3 disease or clear cell carcinoma only)
- •Stage IIB-IV disease (all grades and all histological types)
- •Must have undergone initial surgery (e.g., debulking cytoreductive surgery or a biopsy if the patient has stage IV disease) within the past 6 weeks
- •Patients with stage IV disease for which initial surgical debulking was not appropriate are eligible provided the following criteria are met:
- •Stage IV disease diagnosed by histology
- •No planned surgery prior to disease progression, including interval debulking surgery
- •Patients with prior early-stage ovarian epithelial or fallopian tube carcinoma treated with surgery alone are eligible at the time of diagnosis of abdominopelvic recurrence provided no further interval cytoreductive therapy is planned prior to disease progression
- •Synchronous primary endometrial carcinoma or a past history of primary endometrial carcinoma allowed provided the following criteria are met:
- •Disease ≤ stage IB
- •No more than superficial myometrial invasion
- •No lymphovascular invasion
- •Not poorly differentiated (i.e., no grade 3, papillary serous, or clear cell disease)
- •Measurable or nonmeasurable disease
- •No ovarian nonepithelial cancer, including malignant mixed Müllerian tumors
- •No borderline tumors (e.g., tumors of low malignant potential)
- •No history or clinical suspicion of brain metastases or spinal cord compression
- •CT scan or MRI of the brain is mandatory (within 4 weeks prior to randomization) in case of suspected brain metastases
- •Spinal MRI is mandatory (within 4 weeks prior to randomization) in case of suspected spinal cord compression
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy > 12 weeks
- •ANC ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 9 g/dL (can be post-transfusion)
- •INR ≤ 1.5
- •APTT ≤ 1.5 times upper limit of normal (ULN)
- •Bilirubin ≤ 1.5 times ULN
- •ALT and AST ≤ 2.5 times ULN
- •Creatinine ≤ 2.0 mg/dL
- •Proteinuria ≤ 1+ by urine dipstick OR ≤ 1 g by 24-hour urine collection
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for ≥ 6 weeks after completion of study therapy
- •No significant traumatic injury within the past 4 weeks
- •No cerebrovascular accident, transient ischemic attack, or subarachnoid hemorrhage within the past 6 months
- •No other malignancies within the past 5 years except for adequately treated carcinoma in situ of the cervix, and/or basal cell skin cancer, and/or early endometrial carcinoma
- •No pre-existing sensory or motor neuropathy ≥ grade 2
- •No history or evidence of CNS disease (e.g., uncontrolled seizures) by neurological examination unless adequately treated with standard medical therapy
- •No history or evidence of thrombotic or hemorrhagic disorders
- •No uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg despite antihypertensive therapy)
- •No known hypersensitivity to bevacizumab and its excipients, chemotherapy, or Cremophor EL
- •No nonhealing wound, ulcer, or bone fracture
- •Patients with granulating incisions healing by secondary intention with no evidence of facial dehiscence or infection are eligible but require three weekly wound examinations
- •No clinically significant cardiovascular disease, including any of the following:
- •Myocardial infarction or unstable angina within the past 6 months
- •New York Heart Association class II-IV congestive heart failure
- 另有 19 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
- Duration of overall survival
- Objective response rate
- Duration of response
- Biological progression-free interval as measured by increasing CA 125 levels
- Safety as measured by NCI CTAE version 3.0
- Quality of life
- Health economics
研究者
研究点 (142)
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