NCT00744718已完成2 期
Bevacizumab and Carboplatin for Patients With Platin Resistant Epithelial Ovarian Cancer. A Phase II Study.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Progression free survival
研究概览
简要总结
This is a phase II trial to investigate the effect of bevacizumab and carboplatin in patients with platin resistant ovarian cancer.
研究设计
- 研究类型
- Interventional
- 干预模型
- Factorial
- 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
- •Histologically verified epithelial ovarian cancer, primary tubae- or primary peritoneal cancer (Stage I-IV)
- •Carboplatin resistant ovarian cancer previously treated with a maximum of three different cytostatic regimens (single substance or in combination).
- •Age ≥ 18 years.
- •Performance status 0-
- •Measurable disease according to CA125 GCIG criteria (Gynaecologic Cancer Intergroup) or RECIST (Response Evaluation Criteria in Solid Tumors) (See appendix I+II)
- •Adequate bonemarrow, liver and kidney function and coagulation parameters (within seven days of start of treatment).
- •ANC ≥ 1.5*109
- •Thrombocytes ≥ 100*10^9/L
- •Haemoglobin (Hb) ≥ 6 mmol/l
- •Se-bilirubin (BR) ≤ 1.5*ULN (Upper Limit of Normal)
- •Se-transaminase ≤ 2.5*ULN
- •Se-creatinin ≤ 1.5*ULN
- •Urin stix for protein <2+ (If stix shows protein ≥2+ urin must be measured 24 hours where the protein content must be under 1 g.)
- •APTT ≤ 1.5*ULN
- •Signed informed consent form.
排除标准
- •Patients who have received other types of experimental treatment or participated in a clinical study less than 28 days prior to this study.
- •Pregnant or breastfeeding women. A negative pregnancy test is mandatory for fertile women.
- •Fertile women, who do not wish to use safe contraception (e.g., birth control pills, coil, gestagen deposit injection, subdermal implantation, hormonal vagina ring, and transdermal deposit band-aid).
- •Untreated bowel obstruction or massive gastrointestinal tumors verified by CT scan.
- •Other present or previous malignant disease apart from curatively treated non-melanoma skin cancer or other types of cancer with minimal risk of relapse.
- •CNS-metastases.
- •Underlying medical disease not adequately treated (diabetes, cardiovascular disease).
- •Uncontrolled hypertension (persistent BP > 150/100 despite antihypertensive treatment).
- •Surgery incl. open biopsy less than 4 weeks before expected first dose of Bevacizumab.
- •Patients with non-healing wounds or fractures.
- •Previous cerebrovascular attack (TVA), transient ischaemic attack (TIA) or subarachnoidal bleeding (SAH) within last six months.
- •Thromboembolic or haemorrhagic disease in the anamnesis.
- •Clinically significant cardiovascular disease including Myocardial infarction or unstable angina less than 6 months prior to treatment
- •New York heart Association NYHA class ≥ 2
- •Poorly controlled cardial arrythmia despite medical treatment
- •Peripheral vascular disease, grade 3 or above.
- •Present or previous chronical use of Aspirin (less than 10 days before start of treatment) Aspirin > 325 mg daily.
- •Present or recent use of full dose oral or parenteral anticoagulant or thrombolytic medicine.
- •Preexisting neuropathy, sensoric or motoric ≥ grade
- •Decreased hearing.
- •Bleeding tumor.
- •Hypersensitivity to the active substance or one or more of the other substances contained in the protocol drugs.
- •Hypersensitivity to products from ovarian cells (CHO) from Chinese hamster or other recombinant or humanized antibodies.
结局指标
主要结局
Progression free survival
时间窗: From date of first treatment until date of verified progression or death. 12 months of follow-up
次要结局
- Overall survival(From date of first treatment until death. Up to 12 months)
- Response rate(Every 9 weeks until progression or death. Up to 12 months)
- Response duration(From date of first documented response until date of progression. Up to 12 months.)
研究者
研究点 (2)
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