NCT01229930已完成2 期
CIRCCa - A Randomized Double Blind Phase II Trial of Carboplatin-Paclitaxel Plus Cediranib Versus Carboplatin-Paclitaxel Plus Placebo in Metastatic/Recurrent Cervical Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 5
- 主要终点
- Overall progression-free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether carboplatin and paclitaxel are more effective when given with or without cediranib maleate in treating patients with cervical cancer that cannot be removed by surgery.
PURPOSE: This randomized phase II trial is studying giving carboplatin and paclitaxel together with cediranib maleate to see how well it works compared with giving carboplatin and paclitaxel together with a placebo in treating patients with metastatic or recurrent cervical cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- To provide preliminary evidence regarding whether the addition of cediranib maleate to a combination of carboplatin and paclitaxel will increase the progression-free survival by 50% from 4 to 6 months in patients with metastatic or recurrent, undetectable cervical carcinoma.
Secondary
- To provide estimates of differences in response, survival, toxicity, quality of life, and pharmacodynamic end-points between the study arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed carcinoma of the cervix, including any of the following subtypes:
- •Squamous cell carcinoma
- •Adenocarcinoma
- •Adenosquamous cell carcinoma
- •Must meet one of the following criteria:
- •Persistent or relapsed inoperable disease after radical radiotherapy within the irradiated pelvis
- •Relapse after radical hysterectomy (after radical radiotherapy to pelvis, if appropriate)
- •Extra pelvic metastases
- •Primary stage IVB disease
- •Not suitable for potentially curative surgical procedure
- •Measurable disease in ≥ 1 marker site
- •No CNS disease, including brain metastases, within the past 6 months
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •Life expectancy > 12 weeks
- •Hemoglobin ≥ 10 g/dL
- •ANC ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Calculated creatinine clearance ≥ 35 mL/min
- •No proteinuria > 1+ on dipstick (on 2 consecutive dipsticks not less than 1 week apart), unless urinary protein is < 1.5 g in a 24-hour period
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •ALT or AST ≤ 2.5 times ULN (≤ 5 times ULN if hepatic metastases present)
- •Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN if hepatic metastases present)
- •Prothrombin ratio (PTR)/INR ≤ 1.5 OR PTR/INR 2.0-3.0 for patients on stable dose of anticoagulant
- •Partial thromboplastin time < 1.2 times control
- •No history of a nervous or psychiatric disorder that would prevent informed consent and compliance
- •No prior malignancy within the past 5 years, except for successfully treated basal cell skin cancer or in-situ breast cancer
- •Not pregnant or nursing
- •Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
- •No uncontrolled infection, defined as infection that cannot be resolved readily with antibiotics prior to trial entry
- •No history of significant gastrointestinal impairment, as judged by the Investigator, that would significantly affect the absorption of cediranib maleate
- •No history of pelvic fistula
- •No history of inflammatory bowel disease
- •No sub-acute or acute intestinal obstruction
- •No significant traumatic injury within the past 4 weeks
- •No non-healing wound, ulcer, or bone fracture
- •No active bleeding
- •No history or evidence of thrombotic or hemorrhagic disorders
- •No uncontrolled seizures, cerebrovascular accident, transient ischemic attack, or subarachnoid hemorrhage within the past 6 months
- •No significant cardiovascular disease, including any of the following:
- •Arterial thrombotic event within the past 12 months
- •Angina within the past 6 months
- •History of poorly controlled or uncontrolled hypertension or resting BP > 150/100 mm Hg in the presence or absence of a stable regimen of anti-hypertensive therapy within the past 6 months
- •NYHA class II-IV congestive heart failure
- •Peripheral vascular disease ≥ grade 3 or cardiac arrhythmia requiring medication
- •Prolonged QTc (corrected) interval of > 470 ms on ECG or a family history of long QT syndrome
- •Patients with rate-controlled atrial fibrillation are eligible
- •Not requiring intravenous nutritional support
- •No preexisting sensory or motor neuropathy ≥ grade 2
- 另有 22 项未显示
排除标准
- 未提供
结局指标
主要结局
Overall progression-free survival
次要结局
- Quality of life assessed using EORTC QLQ-C30 and CX24
- Reduction in plasma VEGFR2 levels from baseline to day 28
- Toxicity assessed using NCI CTCAE v4.0
- Response to chemotherapy using RECIST1.1 criteria
- Overall survival
研究者
研究点 (5)
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