ISRCTN68510403已完成3 期
A double-blind, placebo-controlled, three-arm, randomised, multi-centre Gynaecologic Cancer InterGroup trial of cediranib (AZD2171), in combination with platinum-based chemotherapy and as a single agent maintenance therapy, in women with ovarian cancer relapsing more than 6 months following completion of first-line platinum-based treatment
Medical Research Council (UK)0 个研究点目标入组 470 人开始时间: 2007年8月13日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 470
研究概览
简要总结
2011 Results article in http://www.ncbi.nlm.nih.gov/pubmed/21878941 results 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27025186 results 2017 Results article in http://www.ncbi.nlm.nih.gov/pubmed/28339098 quality of life results 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31347385/ results (added 02/09/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33610123/ (added 01/11/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Females aged 18 years or older with previous histologically proven diagnosis of:
- •1.1. Epithelial ovarian carcinoma
- •1.2. Fallopian tube carcinoma
- •1.3. Primary serous peritoneal carcinoma
- •Relapsing more than 6 months after completion of first-line platinum-based chemotherapy
- •2. Signed informed consent and ability to comply with the protocol
- •3. Ability to commence treatment within 2 weeks of randomisation
- •4. Computerised Tomography (CT) or Magnetic Resonance Imaging (MRI) proven relapsed disease, more than six months since completion of first-line platinum-based chemotherapy
- •5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •6. Life expectancy more than 12 weeks
- •7. If there is a past history of a solid tumour, this must have been treated curatively more than five years ago with no evidence of recurrence
- •8. Adequate bone marrow function
- •8.1. Absolute Neutrophil Count (ANC) greater than or equal to 1.5 x 109/l
- •8.2. Platelets (Plt) greater than or equal to 100 x 109/l
- •8.3. Haemoglobin (Hb) greater than or equal to 9g/dl (can be post transfusion)
- •9. Adequate liver function (within 14 days before randomisation)
- •9.1. Serum bilirubin (BR) = 1.5 x Upper Limit of Normal (ULN)
- •9.2. Serum transaminases = 2.5 x ULN
- •10.Adequate renal function
- •10.1. Serum creatinine = 1.5 ULN
- •10.2. Urine dipstick for proteinuria less than 2+. If urine dipstick is greater than or equal to 2+ on two occasions more than one week apart then a 24 hour urine must demonstrate less than or equal to 1 g of protein in 24 hours
排除标准
- •1. Non-epithelial ovarian cancer, including malignant mixed Mullerian tumours and mucinous carcinoma of the peritoneum
- •2. Poorly controlled hypertension (persistently elevated >150/100 mmHg despite anti-hypertensive medication)
- •3. History of inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- •4. Malignancies other than ovarian cancer within 5 years prior to randomisation, except for adequately treated carcinoma in situ of the cervix and/or basal cell skin cancer. Patients who have a past history of a solid tumour, treated curatively, more than five years prior to randomisation, with no evidence of recurrence, are still eligible to enter ICON6
- •5. Previous radiotherapy within 21 days prior to randomisation
- •6. Treatment with any other investigational agent within 30 days prior to entering this trial. Patients are still eligible for entry into ICON6 if they have received previous treatment for ovarian cancer with either bevacizumab, erlotinib, or a Cox-2 inhibitor as long as more than 30 days have elapsed since the last treatment
- •7. Arterial thrombotic event (including Transient Ischaemic Attack [TIA], cerebrovascular accident [CVA) and peripheral arterial embolus) within the previous 12 months
- •8. Gastrointestinal (GI) impairment that could affect ability to take, or adsorption of, oral medicines including sub acute or complete bowel obstruction
- •9. Known hypersensitivity to AZD2171 or other Vascular Endothelial Growth Factor (VEGF) inhibitors
- •10. Major surgery within 2 weeks before entry into the trial
- •11. Significant haemorrhage of >30 ml in a single episode within 3 months or any haemoptysis
- •12. Evidence of severe or uncontrolled cardiac disease
- •12.1. Myocardial Infarct (MI) or unstable angina within 12 months
- •12.2. New York Health Association (NYHA) = grade 2 Congestive Heart Failure (CHF)
- •12.3. Cardiac ventricular arrhythmias requiring medication
- •12.4. History of 2nd or 3rd degree atrioventricular conduction defects
- •13. Prolonged QTc (corrected) interval of >470 msec on electrocardiogram (ECG), or a family history of long QT syndrome
- •14. Persisting = Grade 2 CTC (Common Toxicity Criteria) toxicity (except alopecia and neuropathy) from previous anti-cancer treatment. If peripheral sensory or motor neuropathy = grade 2 then paclitaxel can be omitted from the chemotherapy at the discretion of the treating physician
- •15. History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI of the brain is mandatory in the case of suspected brain metastases. Spinal MRI is mandatory in the case of suspected spinal cord compression. Patients with unstable untreated brain or meningeal metastases are not eligible
- •16. Inability to attend or comply with treatment or follow-up scheduling
- •17. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug or puts the patient at high risk for treatment-related complications
- •18. Fertile women of childbearing potential not willing to use adequate contraception for the duratio
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