EUCTR2009-011400-33-IT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
- •1. Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patients awareness and willingness to comply with the study requirements. 2. Patients >= 18 years of age. 3. 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. 4. Patients must have platinum-resistant disease, (defined as progression within <6 months of platinum therapy) 5. Patients must have disease that is measurable according to RECIST or assessable according to the GCIG CA-125 criteria and require chemotherapy treatment. 6. ECOG PS 02. 7. 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Cancer-related 1. Patients whose disease was refractory to their previous treatment. Refractory disease is defined by those patients who progressed during the preceding treatment. 2. Non-epithelial, including malignant mixed M?llerian tumours. 3. Ovarian tumours with low malignant potential (i.e. borderline tumours). 4. Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer Prior, current or planned treatment: 5. Previous treatment with >2 chemotherapy regimens. 6. Any prior radiotherapy to the pelvis or abdomen. 7. Surgery (including 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 antibody (only applicable to those patients with nonmeasurable disease by RECIST). 10. Current or recent (within 10 days prior to the first study drug dose) chronic daily treatment with aspirin (>325 mg/day). 11. 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. 12. Chronic daily treatment with corticosteroids (dose >10 mg/day methylprednisolone equivalent), excluding inhaled steroids. Laboratory: 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. (In patients receiving anticoagulants (such as warfarin) INR must be between 2.0 and 3.0 in two consecutive measurements 1-4 days apart). 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. Prior or concomitant conditions or procedures: 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. 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). Et al.
研究者
相似试验
进行中（未招募）
不适用
A study of bevacizumab plus chemotherapy versus chemotherapy alone in patients with ovarian cancer.Platinum-resistant, epithelial ovarian, fallopian tube or primary peritoneal cancerMedDRA version: 16.1Level: PTClassification code 10061344Term: Peritoneal neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.1Level: PTClassification code 10016180Term: Fallopian tube cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.1Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2009-011400-33-DKF. Hoffmann-La Roche Ltd361
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. - AURELIAEUCTR2009-011400-33-FIF. Hoffmann-La Roche Ltd332
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. - AURELIAPlatinum-resistant, epithelial ovarian, fallopian tube or primary peritoneal cancerMedDRA version: 9.1Level: LLTClassification code 10033128Term: Ovarian cancerMedDRA version: 9.1Level: LLTClassification code 10016180Term: Fallopian tube cancerMedDRA version: 9.1Level: LLTClassification code 10061344Term: Peritoneal neoplasmEUCTR2009-011400-33-FRF. Hoffmann-La Roche Ltd300
进行中（未招募）
不适用
A study of bevacizumab plus chemotherapy versus chemotherapy alone in patients with ovarian cancer.EUCTR2009-011400-33-NLF. Hoffmann-La Roche Ltd361
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. - AURELIAPlatinum-resistant, epithelial ovarian, fallopian tube or primary peritoneal cancerMedDRA version: 9.1Level: LLTClassification code 10033128Term: Ovarian cancerMedDRA version: 9.1Level: LLTClassification code 10016180Term: Fallopian tube cancerMedDRA version: 9.1Level: LLTClassification code 10061344Term: Peritoneal neoplasmEUCTR2009-011400-33-PTF. Hoffmann-La Roche Ltd332