Randomized Phase II Study of Carboplatin and Paclitaxel +/- Cetuximab, in Advanced and/or Recurrent Cervical Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 108
- 试验地点
- 14
- 主要终点
- event free survival
研究概览
简要总结
This study aims to assess the activity of a combination of cetuximab (weekly) with carboplatin + paclitaxel (every three weeks) comparing it to chemotherapy alone in terms of event-free survival (EFS).
详细描述
The poor long-term results in the standard treatment of chemotherapy for cervical cancer make research into new, more beneficial treatment strategies necessary. Cetuximab is a new type of drug that blocks the epidermal growth factor receptor (anti-EFGR), and has shown significant activity in other cancers (colon, head and neck) where expression of EGFR is high. Cervical cancer cells express EGFR in a very high proportion of cases, especially in recurrent or resistant disease. This study evaluates the activity of the addition of cetuximab to full doses of carboplatin and paclitaxel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Advanced and/or metastatic cervical cancer patients untreated or having failed only one previous chemotherapy (with at least 6 months of progression free interval, with or without concomitant or sequential radiotherapy).
- •At baseline, presence of at least one measurable target lesion (a lesion that can be accurately measured in at least one dimension i.e. longest diameter at least 20 mm with conventional CT scan or at least 10 mm with spiral CT scan according to RECIST Criteria).
- •Not amenable to surgery and/or radiotherapy.
- •PS 0-1 according to ECOG.
- •Life expectancy of at least 3 months.
- •Adequate organ functions
- •Hematopoietic: Leukocytes > 3,000/mm3; Absolute neutrophil count > or = 1,500/mm3; Platelets count > or = 100,000/mm3; Hemoglobin > or = 9 g/dL
- •Hepatic: AST and ALT < or = 3 times upper limit of normal (ULN)*; Alkaline phosphatase < or = 3 times ULN*; Bilirubin < or = 1.5 times ULN
- •*: < or = 5 times ULN if liver metastases are present
- •Renal: Creatinine clearance > or = 45 mL/min
- •No other invasive malignancy within the past 5 years except non-melanoma skin cancer.
- •All radiology studies must be performed within 28 days prior to randomization.
- •Absence of any psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule.
- •Written informed consent.
排除标准
- •Pregnant (potentially fertile patients must use contraceptive measures to avoid pregnancy during and for at least 3 months after study participation and must have a negative serum pregnancy test at baseline).
- •Patients should not be breast-feeding during treatment and for 2 months following the end of treatment.
- •More than one previous chemotherapy line.
- •Active infection requiring antibiotics.
- •Symptomatic peripheral neuropathy >grade 2 according to the CTCAE.
- •Congestive heart failure or angina pectoris even if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled high risk hypertension or arrhythmia.
- •Known hypersensitivity to the study drugs or to drugs with similar chemical structures.
- •Concurrent treatment with other experimental drugs.
- •Participation in another clinical trial with any investigational drug within 30 days prior to study screening.
研究组 & 干预措施
Arm B
chemotherapy
干预措施: paclitaxel (Drug)
Arm B
chemotherapy
干预措施: carboplatin (Drug)
Arm A
chemotherapy plus cetuximab
干预措施: paclitaxel (Drug)
Arm A
chemotherapy plus cetuximab
干预措施: carboplatin (Drug)
Arm A
chemotherapy plus cetuximab
干预措施: cetuximab (Drug)
结局指标
主要结局
event free survival
时间窗: after 3 and 6 cycles of treatment (each cycle is 21 days), and every 3 months thereafter up to 18 months
次要结局
- adverse events(after each treatment cycle (each cycle is 21 days) up to 30days)
- EGFR/KRAS expression and correlation with cetuximab activity(at 18 months)
- overall survival(18 months)
- skin toxicity and correlation with cetuximab activity(after 3 and 6 cycles of therapy (each cycle is 21 days), and every 3 months thereafter up to 18 months)