EUCTR2011-001015-32-SE进行中（未招募）1 期
A multi-centre, open-label, randomised, twoarm Phase III trial to evaluate optimal treatment duration of first-line bevacizumab in combination with carboplatin and paclitaxel in patients with primary epithelial ovarian, fallopian tube or peritoneal cancer. - BOOST/OVAR-17
AGO Research GmbH, AGO Study Group0 个研究点目标入组 900 人开始时间: 2012年11月9日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 900
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Signed written informed consent obtained prior to initiation of any studyspecific
- •procedures and treatment as confirmation of the patients awareness and willingness to comply with the study requirements.
- •2. Primary diagnosis is confirmed by specialized pathology review (Germany only)
- •3. Females aged = 18 years
- •4. Histologically confirmed, newly diagnosed
- •Epithelial ovarian carcinoma
- •Fallopian tube carcinoma
- •Primary peritoneal carcinoma
- •AND FIGO stage IIb - IV (all grades and all histological types)
- •5. Patients should have already undergone surgical debulking, by a surgeon experienced
- •in the management of ovarian cancer, with the aim of maximal surgical cytoreduction according to the GCIG Conference Consensus Statement. There must be no planned surgical debulking prior to disease progression. Patients with stage III and IV disease in
- •whom initial surgical debulking was not appropriate or possible will still be eligible providing
- •the patient has a histological diagnosis and
- •debulking surgery prior to disease progression is not foreseen
- •6. Patients must be able to commence cytotoxic chemotherapy within 8 weeks of cytoreductive surgery. The first dose of bevacizumab can be omitted in both arms if the investigator decides to start chemotherapy within 4 weeks of surgery
- •7. ECOG performance status (PS) 0-2
- •8. Life expectancy > 3 months
- •9. Adequate bone marrow functiona (within 14 days prior to randomization)
- •Absolute Neutrophil Count (ANC) = 1.5 x 109/L
- •Platelets (PLT) = 100 x 109/L
- •Hemoglobin (Hb) = 9 g/dL (can be post-transfusion)
- •10. Adequate coagulation parametersa (within 14 days prior to randomization)
- •Patients not receiving anticoagulant medication who have an International Normalised Ratio (INR) = 1.5 and an Activated ProThrombin Time (aPTT) = 1.5 x ULN
- •The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to institution medical standard) and the patient has been on a stable dose of anticoagulants for at least two weeks at the time of randomization
- •11. Adequate liver functiona (within 14 days prior to randomization)
- •Serum bilirubin = 1.5 x ULN
- •Serum transaminases = 2.5 x ULN
- •12. Urine dipstick for proteinuria < 2+. If urine dipstick is = 2+, 24 hour urine must
- •demonstrate = 1 g of protein in 24 hours
- •13. Adequate postoperative glomerulare filtration rate > 40 ml/min (estimates based on the Cockroft-Gault or Jelliffe formula are sufficient)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 900
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Non-epithelial origin of the ovary, the fallopian tube or the peritoneum
- •2. Borderline tumours (tumours of low malignant potential) and FIGO stage Ia – IIa
- •3. Planned intraperitoneal cytotoxic chemotherapy
- •4. Prior systemic anti-cancer therapy for ovarian cancer (for example chemotherapy,
- •monoclonal antibody therapy, tyrosine kinase inhibitor therapy or hormonal therapy)
- •5. Surgery (including open biopsy) within 4 weeks prior to anticipated first dose of bevacizumab (allowing for the fact that bevacizumab can be omitted from the first cycle of chemotherapy).
- •It is strongly recommended that an interval of 7 days is left between the insertion of any central venous access devices (CVADs) and the onset of bevacizumab treatment.
- •6. Any planned surgery during the study treatment period plus 4 additional weeks to allow for bevacizumab clearance
- •7. Uncontrolled hypertensionb (sustained elevation of BP systolic > 150mmHg and/or diastolic > 100mmHg despite antihypertensive therapy)
- •8. Any previous radiotherapy to the abdomen or pelvis
- •9. Significant traumatic injury during 4 weeks preceding the potential first dose of bevacizumab
- •10. History or clinical suspicion of brain metastases or spinal cord compression. CT/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
- •11. History or evidence upon neurological examination of central nervous system (CNS) disease, unless adequately treated with standard medical therapy e.g. uncontrolled seizures
- •12. Previous Cerebro-Vascular Accident (CVA), Transient Ischaemic Attack (TIA) or Sub-Arachnoid Haemorrhage (SAH) within 6 months prior to randomization
- •13. Fertile woman of childbearing potential not willing to use adequate contraception
- •(oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) for the study duration and at least 6 months afterwards
- •14. Pregnant or lactating women
- •15. Treatment with other investigational agents, or participation in another clinical
- •trial testing a drug within the past 4 weeks before start of therapy concomitantly with this trial
- •16. Malignancies other than ovarian cancer within 5 years prior to randomization, except
- •for adequately treated
- •- carcinoma in situ of the cervix
- •- and/or basal cell skin cancer
- •- and/or non-melanomatous skin cancer
- •- carcinoma in situ of the breast
- •- and/or early endometrial carcinoma
- •as specified below. Patients may have received previous adjuvant chemotherapy for other malignancies e.g. breast or colorectal carcinoma if diagnosed over 5 years ago with no evidence of subsequent recurrence
- •17. Patients with synchronous primary endometrial carcinoma, or a past history of primary endometrial carcinoma, are excluded unless ALL of the following criteria for describing the endometrial carcinoma are met
- •Disease stage FIGO stage = IA (tumour invades less than one half of the myometrium)
- •18. Known hypersensitivity to bevacizumab and its excipients, Chinese hamster ovary
- •cell products or other recombinant human or humanised antibodies
- •19. Non healing wound, active ulcer or bone fracture. Patients with granulating incisions
- •healing by secondary intention with no evidence of facial dehiscence or infection are eligible but require 3 weekly wound examinations
- •20. History or
研究者
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