EUCTR2004-002473-23-ES进行中（未招募）不适用
PHASE II TRIAL OF THE SEQUENTIAL ADMINISTRATION OF COMBINATIONS OF GEMCITABINE-CISPLATIN AND CARBOPLATIN-PACLITAXEL FOR THE TREATMENT OF PATIENTS WITH ADVANCED CARCINOMA OF THE OVARY WITH SUB-OPTIMAL CYTOREDUCTIO
Dr. Amalia Velasco0 个研究点目标入组 54 人开始时间: 2005年11月4日最近更新:
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
- 54
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
- •1.Diagnosis of epithelial carcinoma of the ovaries, of any histological type, in FIGO stage IIIB, IIIC, IV, or primary peritoneal carcinoma, with sub-optimal residual disease (> 1 cm). In all patients, an attempt must be made at surgical cytoreduction and there must be a histological or cytological confirmation of the tumour. In patients with pleural effusion, a diagnostic thoracentesis with cytological study of the pleural fluid. No more than 12 weeks must have passed since first surgery or diagnosis of the tumour.
- •2.Patients must present measurable disease taking into account RECIST criteria, or demonstrated disease if in addition they `present raised levels of tumour marker (Ca 125).
- •3.Patients must not have received any prior chemotherapy treatment for their condition.
- •4.Functional status from 0-2 on the ECOG scale.
- •5.Life expectancy greater than 12 weeks.
- •6.Age equal to or greater than 18 years.
- •7.Adequate marrow reserve, defined as haemoglobin = 10 g/dL, platelets = 100,000/mm3 and absolute granulocyte count = 1,500/mm3.
- •8.Adequate hepatic and renal function, defined as: bilirubin ? 1.5 times above the normal value; GOT and GPT < 3 times greater than the normal range (both may be raised up to 5 times in excess of the normal value in patients with known hepatic metastases); and creatinine < 1.5 mg/dL.
- •9.Use of an appropriate contraceptive method during the trial and in the subsequent 3 months in those cases where pregnancy is possible.
- •10.Patients must be capable of ensuring adequate compliance with therapy and live sufficiently near to the treatment location to allow appropriate follow-up.
- •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
- •1.Borderline ovarian tumours.
- •2.Severe uncontrolled active infection, according to the researcher’s criteria.
- •3.Pregnancy or period of breastfeeding.
- •4.Severe neuropathy degree ? 2.
- •5.Presence of severe arrhythmias requiring medical treatment.
- •6.Any serious concomitant disease in the investigator’s opinion.
- •7.Prior treatment with chemotherapy or radiation therapy for any reason.
- •8.Prior participation in any other protocol for the investigation of experimental medications during the 30 days prior to recruitment of the patient.
- •9.Prior diagnosis of malignant disease (except appropriately treated carcinoma of the cervix in situ or non-melanoma skin carcinoma).
- •10.Patient only with raised tumour marker (Ca 125) without demonstrable disease by any other means.
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