ISRCTN23516549已完成2 期
CIRCCa (Cediranib In Recurrent Cervical Cancer): a randomised double-blind phase II trial of carboplatin-paclitaxel plus cediranib versus carboplatin-paclitaxel plus placebo in metastatic/recurrent cervical cancer
HS Greater Glasgow and Clyde0 个研究点目标入组 69 人开始时间: 2009年11月13日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 69
研究概览
简要总结
2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26474517 results
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Female and over 18 years of age
- •2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •3. Histologically proven carcinoma of the cervix (squamous, adenocarcinoma, adenosquamous mixed or small cell)
- •4. Either:
- •4.1. Persistent or relapsed inoperable disease after radical radiotherapy within the irradiated pelvis OR
- •4.2. Relapse after radical hysterectomy (after radical radiotherapy to pelvis if appropriate) OR
- •4.3. Extra pelvic metastases OR
- •4.4. Stage IVb disease at diagnosis
- •5. Patient not suitable for potentially curative surgical procedure
- •6. Measurable disease in at least one marker site
- •7. Adequate haematological function, as follows:
- •7.1. Haemoglobin greater than or equal to 10 g/dl
- •7.2. Neutrophils greater than or equal to 1.5 x 10^9/l
- •7.3. Platelets greater than or equal to 100 x 10^9/l
- •7.4. Calculated creatinine clearance greater than or equal to 35 ml/min (measured by EDTA)
- •8. Adequate biochemical function, as follows:
- •8.1. Bilirubin less than or equal to 1.5 x upper limit of normal (ULN)
- •8.2. Alanine amino-transferase (ALT) or aspartate amino-transferase (AST) less than or equal to 2.5 x ULN (or less than or equal to 5 x ULN if hepatic metastases)
- •9. Adequate coagulation as follows:
- •9.1.1. Prothrombin time ratio (PTR)/international normalised ratio (INR) less than or equal to 1.5 OR
- •9.1.2. PTR/INR between 2.0 and 3.0 for patients on stable doses of anticoagulants
- •9.2. Partial thromboplastin time less than 1.2 x control
- •10. Life expectancy greater than 12 weeks
排除标准
- •1. They have received prior chemotherapy, except cisplatin administered along with radiotherapy as primary treatment
- •2. Relapse is confined to the pelvis after radical surgery in circumstance where radiotherapy or chemoradiotherapy would be appropriate
- •3. Relapse is potentially treatable with exenterative surgery
- •4. History of nervous or psychiatric disorder that would prevent informed consent and compliance
- •5. History of prior malignancy within the previous 5 years except for successfully treated basal cell skin cancer or in-situ breast cancer
- •6. Pregnant or lactating women
- •7. Fertile woman of childbearing potential not willing to use adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) for the study duration and at least six months afterwards
- •8. Evidence of uncontrolled infection
- •9. Tumour involvement of bowel wall
- •10. History of pelvic fistulae
- •11. Sub-acute or acute intestinal obstruction
- •12. Major surgery within 28 days or anticipated while on study
- •13. Significant traumatic injury during 4 weeks preceding the potential first dose of cediranib
- •14. Non-healing wound, ulcer or bone fracture
- •15. Active bleeding
- •16. History or evidence of thrombotic or haemorrhagic disorders
- •17. History of inflammatory bowel disease
- •18. Proteinuria greater than 1+ on dipstick on two consecutive dipsticks taken no less than 1 week apart, unless urinary protein is less than 1.5 g in a 24-hour period
- •19. Significant cardiovascular disease (arterial thrombotic event within 12 months, uncontrolled hypertension or angina within 6 months, New York Heart Association (NYHA) grade 2 congestive cardiac failure, grade greater than or equal to 3 peripheral vascular disease or cardiac arrhythmia requiring medication). Patients with rate-controlled atrial fibrillation are eligible.
- •20. Prolonged QTc (corrected) interval of greater than 470 ms on electrocardiogram (ECG) or a family history of long QT syndrome
- •21. Central nervous system (CNS) disease (brain metastases, uncontrolled seizures or cerebrovascular accident/transient ischaemic attack/subarachnoid haemorrhage within 6 months)
- •22. History or clinical suspicion of spinal cord compression
- •23. Pre-existing sensory or motor neuropathy greater than or equal to grade 2
- •24. Known hypersensitivity to carboplatin or paclitaxel
- •25. 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
研究者
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CIRCCa(Cediranib In Recurrent Cervical Cancer)A Randomised Double Blind Phase II trial of carboplatin-paclitaxel plus cediranib versus carboplatin-paclitaxel plus placebo in metastatic/recurrent cervical cancer - CIRCCa - Cediranib in Recurrent Cervical CancerMetastatic/ Recurrent carinoma of cervixMedDRA version: 13.1Level: PTClassification code 10041848Term: Squamous cell carcinoma of the cervixSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 13.1Level: LLTClassification code 10008224Term: Cervical adenocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2009-011542-25-GBHS Greater Glasgow and Clyde
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