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临床试验/EUCTR2009-011400-33-DE
EUCTR2009-011400-33-DE进行中（未招募）不适用

A multi-centre, open-label, randomise, two-arm Phase III trial of bevacizumab plus chemotherapy versus chemotherapy alone in patients with platinum resistant, epithelial ovarian, fallopian tube or primary peritoneal cancer. - AURELIA

F. Hoffmann-La Roche Ltd0 个研究点目标入组 361 人开始时间: 2009年8月4日最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
361
研究概览入排标准研究者记录与标识符相似试验

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. 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 =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, except for tumours with a negligible risk for metastasis or death.
  • •5. Previous treatment with >2 anticancer regimens.
  • •6. Any prior radiotherapy to the pelvis or abdomen.
  • •7. Surgery (incl. open biopsy) within 4 weeks 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 the 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: <1.5 x 109/l, or platelet count <100 x 109/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 >2.0 mg/dl or >177 µmol/l or calculated creatinine clearance <40ml/min (by Cockroft & Gault formula) 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 standards.
  • •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 (defined as <2 years after last menstruation and not surgically sterile) not using highly-effective, hormonal or non-hormonal 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 cerebrovascular accident (CVA) / stroke or transient ischemic attack (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; New York Heart Association (NY

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