EUCTR2009-010099-74-IT进行中（未招募）不适用
A RANDOMIZED PHASE II STUDY OF CARBOPLATIN AND PACLITAXEL +/- CETUXIMAB, IN ADVANCED AND/OR RECURRENT CERVICAL CANCER - Cetuximab in cervical cancer
ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE0 个研究点开始时间: 2009年4月17日最近更新:
适应症
相关药物
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
- •·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 ³ 20 mm with conventional CT scan or ³ 10 mm with spiral CT scan according to RECIST Criteria).
- •·Not amenable to surgery and/or radiotherapy.
- •·PS 0-1 according to ECOG.
- •·Age >18.
- •·Life expectancy of at least 3 months.
- •·Adequate organ functions
- •-Hematopoietic: Leukocytes > 3,000/mm3; Absolute neutrophil count ≥ 1,500/mm3; Platelets count ≥ 100,000/mm3; Hemoglobin ≥ 9 g/dL
- •-Hepatic: AST and ALT ≤ 3 times upper limit of normal (ULN)*; Alkaline phosphatase ≤ 3 times ULN*; Bilirubin ≤ 1.5 times ULN
- •*: ≤ 5 times ULN if liver metastases are present
- •-Renal: Creatinine clearance ≥ 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.
- •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
- •·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.
研究者
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