Carboplatin Plus Xeloda Followed By Maintenance Xeloda (CARBOX) - CARBOX

The Royal Marsden NHSF Trust0 个研究点目标入组 20 人开始时间: 2006年5月10日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•Recurrent, histologically verified epithelial ovarian carcinoma.
•Measurable disease as assessed by CT in accordance with RECIST guidelines
•No more than 2 lines of prior chemotherapy (either as adjuvant or for metastatic disease).
•There must be a platinum-free interval of at least 6 months between platinum therapy and start of the next chemotherapy.
•A glomerular filtration rate of greater than or equal to 60ml/minute. This can be measured by an EDTA clearance or 24 hour urine collection.
•Serum bilirubin<2 x institutional upper limit of normal.
•Patients should have a projected life expectancy of at least 3 months.
•ECOG performance status 0, 1 or 2.
•Patients must not have a history of other malignant diseases other than treated non-melanotic skin cancer or in situ carcinoma of the uterine cervix.
•Adequate bone marrow function WBC>3x109/l, neutrophils>1.5x109/l, platelets>100x109/l.
•Written informed consent from the patient.
•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

•Any medical or psychiatric condition that impairs the patient’s ability to give informed consent.
•Uncontrolled angina pectoris, heart failure, or clinically significant uncontrolled cardiac arrhythmias.
•Significant abnormal ECG or cardiac history having a LVEF of less than the lower limit of normal for institution as determined by MUGA scan or echocardiogram.
•Any other serious uncontrolled medical conditions
•Pregnancy or lactation (Any woman of child-bearing potential must have a pregnancy test prior to randomisation and must take adequate precautions to prevent pregnancy during treatment).
•Inability to complete the quality of life questionnaire

发起方

The Royal Marsden NHSF Trust