EUCTR2004-001356-37-DK进行中（未招募）不适用
Phase I-II-III studies of Cisplatin and Combretastatin (CA4P) in recurrent or advanced servical cancer
ordic Society for Gynecological Cancer0 个研究点目标入组 420 人开始时间: 2005年8月23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
- 入组人数
- 420
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
- •a) Primary advanced (stage IVB), persistent or recurrent cancer of the uterine cervix considered incurable by surgery, radiotherapy and or chemotherapy.
- •b) Histological verified squamous carcinoma, adenocarcinoma or adeno-squamous carcinoma
- •c) Performance status (WHO) 0 or 1.
- •d) Life expectancy > 12 weeks.
- •e) Age > 18 years and < 75 years.
- •f) For Phase I, a treatment free interval of at least 2 month from previous radiotherapy, chemotherapy or radio-chemotherapy is required.
- •g) For Phase II, at least one measurable lesion (RECIST) outside previously irradiated area with clinical evidence of progression within 6 weeks prior to treatment is required. Progressing lesions localized only to previous irradiated volume is allowed in Phase III.
- •h) For Phase II-III, prior chemotherapy or radio-chemotherapy is allowed provided that a treatment free interval of at least 6 month is at hand. Previous radiotherapy more than 3 month ago is allowed.
- •i) For Phase II-III, patients progressing directly during previous chemotherapy or radio-chemotherapy are ineligible.
- •j) Acceptable bone marrow function (leukocytes ³ 3.0x109/L and platelet count 100x109/L).
- •k) ECG without evidence of prior myocardial infarction (e.g., significant Q waves), QTc > 450 msec. or other clinically significant abnormalities.
- •l) Sufficient kidney function with calculated (Cockroft-Gault) GFR > 50 ml/min and no uncontrolled hypokalemia and/or hypomagnesemia.
- •m) Acceptable liver function with bilirubin < 30 µmol/l.
- •m) Patients with childbearing potential must have a negative pregnancy test and should use an effective method of contraception (hormonal anticonception or intrauterine device).
- •n) Written informed consent according to ICH/EU GCP guidelines and regional and national law.
- •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
- •a) No combination of protocol treatment with attempts of curative surgery or radiotherapy.
- •b) No previous inclusion in the protocol.
- •c) No other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin.
- •d) No CNS metastases.
- •e) No major surgery within 4 weeks.
- •f) No concomitant administration of other antineoplastic agents.
- •g) No palliative radiotherapy unless at least one measurable lesion is left unirradiated.
- •h) No history of angina (stable or more severe, even if controlled with medications), myocardial infarction, chronic heart failure, non-controlled atrial arrhythmias or clinically significant arrhythmias including conduction abnormality, nodal junctional arrhythmias and dysrhythmias, sinus bradycardia or tachycardia, supraventricular arrhythmias, atrial fibrillation or flutter, syncope or vasovagal episodes.
- •i) Patients taking any drug(s) known to prolong the QTc interval, which cannot be interrupted for at least four days during each 7-day treatment cycle or patients with conditions associated with QTc prolongation cannot be included
- •j) No uncontrolled hypertension (defined as blood pressure consistently greater than 150/100 mmHg irrespective of medication).
- •k) No symptomatic peripheral vascular disease or cerebrovascular disease.
- •l) No grade 2 (CTC v.3.0) or greater pre-existing peripheral neuropathy (motor or sensory);
- •m) No psychiatric disorders or other conditions rendering patients incapable of complying with the requirements of the protocol.
- •n) No active infection or other severe medical condition endangering treatment delivery.
- •o) Patients, for whom regular follow-up attendance is impractical, are not eligible.
研究者
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