EUCTR2009-011542-25-GB进行中（未招募）不适用
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 Cancer
HS Greater Glasgow and Clyde0 个研究点开始时间: 2010年3月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Female and over 18 years of age.
- •ECOG performance status 0, or 1.
- •Written Informed Consent
- •Histologically proven carcinoma of the cervix (squamous, adenocarcinoma or adenosquamous mixed ).
- •1.Persistent or relapsed inoperable disease after radical radiotherapy within the irradiated pelvis or
- •2.Relapse after radical hysterectomy (after radical radiotherapy to pelvis if appropriate) or
- •3.Extra pelvic metastases or
- •4.Stage IVb disease at diagnosis
- •Patient not suitable for potentially curative surgical procedure.
- •Measurable disease in at least one marker site.
- •Adequate haematological function, as follows:
- •Haemoglobin > 10g/dl
- •Neutrophils > 1.5 x 109/l
- •Platelets > 100 x 109/l
- •Calculated Creatinine Clearance > 35mls/min (measured
- •Adequate biochemical function, as follows:
- •Bilirubin < 1.5 x ULN
- •ALT or AST < 2.5 x ULN (or =5 x ULN if hepatic
- •metastases present)
- •Alkaline Phosphatase < 2.5 x ULN (or =5 x ULN if hepatic metastases)
- •Adequate coagulation, as follows:
- •Prothrombin ratio (PTR) / INR = 1.5 or
- •PTR / INR between 2.0 and 3.0 for patients on stable doses of anticoagulants
- •Partial thromboplastin time <1.2 x control
- •Life expectancy >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
- •They have received prior chemotherapy, except cisplatin administered along with radiotherapy as primary treatment.
- •Relapse is confined to the pelvis after radical surgery in circumstance where radiotherapy or chemoradiotherapy would be appropriate.
- •Relapse is potentially treatable with exenterative surgery.
- •History of nervous or psychiatric disorder that would prevent informed consent and compliance
- •History of prior malignancy within the previous 5 years except for successfully treated basal cell skin cancer or in-situ breast cancer
- •Pregnant or lactating women.
- •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
- •Evidence of uncontrolled infection.
- •History of pelvic fistulae.
- •Sub-acute or acute intestinal obstruction.
- •Major surgery within 28 days or anticipated while on study.
- •Significant traumatic injury during 4 weeks preceding the potential first dose of cediranib.
- •Non-healing wound, ulcer or bone fracture.
- •Active bleeding.
- •History or evidence of thrombotic or haemorrhagic disorders.
- •History of inflammatory bowel disease.
- •Proteinuria > 1+ on dipstick on two consecutive dipsticks taken no less than 1 week apart, unless urinary protein is <1.5g in a 24 hour period.
- •Significant cardiovascular disease (arterial thrombotic event within 12 months, uncontrolled hypertension or angina within 6 months, NYHA grade 2 congestive cardiac failure, grade = 3 peripheral vascular disease or cardiac arrhythmia requiring medication). Patients with rate-controlled atrial fibrillation are eligible.
- •Prolonged QTc (corrected) interval of >470ms on ECG or a family history of long QT syndrome.
- •CNS disease (brain metastases, uncontrolled seizures or cerebrovascular accident/transient ischaemic attack /subarachnoid haemorrhage within 6 months).
- •History or clinical suspicion of spinal cord compression.
- •Pre-existing sensory or motor neuropathy = grade 2.
- •Known hypersensitivity to carboplatin or paclitaxel
- •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
- •Any unresolved toxicity = CTC Grade 2 from previous systemic anti-cancer therapy except haematological toxicity (see inclusion criteria Adequate haematological function”) and alopecia.
- •A history of poorly controlled hypertension or resting BP>150/100 mmHG in the presence or absence of a stable regimen of anti-hypertensive therapy (measurements will be made after the patient has been resting supine for a minimum of 5 minutes. Two or more readings should be taken at 2 minutes intervals and averaged. If the first two diastolic readings differ by more than 5mmHG, then an additional reading should be obtained and averaged).
- •Requiring intravenous nutritional support.
- •History of significant gastrointestinal impairment, as judged by the Investigator, that would significantly affect the absorption of cediranib.
研究者
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