EUCTR2009-011400-33-FR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 primary peritoneal 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
- 300
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
- •. 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.
- •. Patients =18 years of age
- •. 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.
- •. Patients must have platinum-resistant disease, (defined as progression within <6
- •months of platinum therapy)
- •. Patients must have disease that is measurable according to RECIST or assessable
- •according to the GCIG CA-125 criteria and require chemotherapy treatment.
- •. ECOG PS 0–2.
- •. 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •. Non-epithelial, including malignant mixed Müllerian tumours.
- •. Ovarian tumours with low malignant potential.
- •. Other malignancy within the last 5 years
- •. Minor surgical procedures within 24 hours prior to first study treatment.
- •. Previous exposure to murine CA-125 Ab (only applicable to those patients
- •with non-measurable disease by RECIST).
- •. Current or recent treatment with another investigational drug and/or
- •participation in another investigational study within 30 days of first study
- •treatment dosing or earlier participation in this study.
- •. Chronic daily treatment with corticosteroids, excluding inhaled steroids.
- •. Inadequate bone marrow function: ANC: <1.5 x 10E9/l, or platelet count <100 x
- •10E9/l, or haemoglobin <9 g/dl. Patients may be transfused to maintain
- •haemoglobin values >9 g/dl.
- •. 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.
- •. 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).
- •. Inadequate renal function, defined as serum creatinine >2.0 mg/dl or >177
- •µmol/l or calculated creatinine clearance <40ml/min for patients intended to be
- •treated with topotecan. urine dipstick for proteinuria >2+. Patients with greater
- •than or equal to 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
- •. Pre-existing peripheral neuropathy =CTC grade 2.
- •. 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).
- •. Women of childbearing potential not using highly-effective, non-hormonal means
- •of contraception (intrauterine contraceptive device or barrier method of
- •contraception in conjunction with spermicidal jelly) during the study and for 6
- •months after the last dose of study medication.
- •. LVEF defined by MUGA/ECHO below the institutional lower limit of normal (only
- •applicable for patients intended to be treated with PLD).
- •. Serious active infection requiring i.v. antibiotics and/or hospitalisation at study
- •. Known hypersensitivity to any of the study drugs or excipients.
- •. Evidence of any other medical conditions, physical examination or laboratory
- •findings that may interfere with the planned treatment, affect patient compliance
- •or place the patient at high risk from treatment-related complications.
研究者
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