EUCTR2009-011400-33-BE进行中（未招募）不适用
A multi-centre, open-label, randomised, two-arm Phase III trial of bevacizumab plus chemotherapy versus chemotherapy alone in patients with platinum-resistant, epithelial ovarian, fallopian tube or primaryperitoneal cancer. - AURELIA
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 361
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 informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient’s awareness and willingness to comply with the study requirements.
- •2. Patients =18 years of age with histologically confirmed and documented disease. The following histological types are eligible:
- •adenocarcinoma NOS
- •clear cell adenocarcinoma
- •endometriod adenocarcinoma
- •malignant Brenner's tumour
- •mixed epithelial carcinoma
- •mucinous adenocarcinoma
- •serous adenocarcinoma
- •transitional cell carcinoma
- •undifferentiated carcinoma.
- •3. Patients must have platinum-resistant disease (defined as progression within <6
- •months from completion of a minimum of 4 platinum therapy cycles. The date should be calculated from the last administered dose of platinum therapy).
- •4. Patients must have disease that is measurable according to RECIST or assessable according to the GCIG CA-125 criteria and require chemotherapy treatment.
- •5. ECOG PS 0–2.
- •6. Life expectancy of greater than or equal to 12 weeks.
- •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 228
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 133
排除标准
- •1. Patients whose disease was refractory to their previous platinum treatment.
- •2. Non-epithelial, including malignant mixed Müllerian tumours.
- •3. Ovarian tumours with low malignant potential.
- •4. History of other clinically active malignancy within 5 years of enrollment
- •5. Previous treatment with >2 anticancer regimens.
- •6. Any prior radiotherapy to the pelvis or abdomen.
- •7. Surgery (incl. open biopsy) within 4 wks prior to the start of study, or anticipation of the need for major surgery during study treatment.
- •8. Minor surgical procedures within 24 hours prior to first study treatment.
- •9. Previous exposure to murine CA-125 Ab (only applicable to those patients with non-measurable disease by RECIST).
- •10. Current or recent chronic daily treatment with aspirin (>325 mg/day).
- •11. Current or recent treatment with another investigational drug within 30 days of first study treatment dosing or earlier participation in this study.
- •12. Chronic daily treatment with corticosteroids, excluding inhaled steroids.
- •13. Inadequate bone marrow function: ANC: <1.5x10E9/l, or platelet count <100x10E9/l, or haemoglobin <9 g/dl. Patients may be transfused to maintain haemoglobin values >9 g/dl.
- •14. Inadequate coagulation parameters: aPTT >1.5 x ULN (patients on heparin treatment must have an aPTT between 1.5 - 2.5 x ULN), or INR >1.5.
- •15. Inadequate liver function, defined as: serum (total) bilirubin >1.5 x ULN for the
- •institution; alkaline phosphatase, AST/SGOT or ALT/SGPT >2.5 x ULN (or 5 x ULN in the presence of liver metastases).
- •16. Inadequate renal function, defined as serum creatinine >2.0mg/dl or >177µmol/l or calculated creatinine clearance <40ml/min for patients intended to be treated with topotecan. urine dipstick for proteinuria >2+. Patients with =2+ proteinuria on baseline dipstick analysis should undergo a 24-hour urine collection and must demonstrate =1 g of protein in the 24-hour urine. Alternatively, proteinuria testing can be performed according to local
- •17. History or evidence upon physical/ neurological examination of CNS disease unrelated to cancer, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures).
- •18. Symptomatic CNS metastasis
- •19. Pre-existing peripheral neuropathy =CTC grade 2 for those patients planned to receive paclitaxel.
- •20. Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days (with a confirmatory urine pregnancy test within 7 days prior to study treatment start).
- •21. Women of childbearing potential not using highly-effective, hormonal or nonhormonal means of contraception (i.e. intrauterine contraceptive device) during
- •the study and for 6 months after the last dose of study medication.
- •22. History or evidence of thrombotic or hemorrhagic disorders; including CVA/stroke or TIA or sub-arachnoid haemorrhage within =6 months prior to the first study treatment.
- •23. Uncontrolled hypertension (sustained systolic >150 mmHg and/or diastolic >100
- •mmHg despite antihypertensive therapy) or clinically significant (i.e. active cardiovascular disease, including: myocardial infarction or unstable angina within =6 months prior to the first study treatment; NYHA grade II or greater CHF;
- •serious cardiac arrhythmia requiring medication (with the exception of atrial
- •fibrillation or paroxysmal supraventricular tachycardia); peripheral vascular disease >grade 3.
- •24. LVEF defined by MUGA/ECHO below
研究者
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