EUCTR2009-011922-33-DE进行中（未招募）不适用
A randomized, double-blind, placebo controlled, multicenter Phase II study to assess the efficacy and safety of Sorafenib added to standard treatment with Topotecan in patients with platinum-resistant recurrent ovarian cancer - TRIAS 2009
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 184
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.Patients with histologically confirmed epithelial ovarian cancer, primary peritoneal carcinomatosis or fallopian tube cancer
- •2.Patients must have platinum resistant (relapse-free interval < 6 months of a platinum-containing primary or secondary or tertiary therapy) or platinum refractory (progression during primary or secondary or tertiary platinum treatment) disease defined by measurable disease according to RECIST or elevated CA-125 level according the GCIG-criteria.
- •Definition of relapse: Demonstration of measurable or non-measurable tumour according to RECIST criteria by an imaging procedure (where applicable before relapse surgery) or increase in the tumour marker CA-125 to twice the upper laboratory value of normal for the hospital or histological confirmation of tumour relapse by biopsy or surgery.
- •3.No more than 2 prior treatment regimens for recurrent epithelial ovarian cancer.
- •4.Elevated CA-125-value before study entry in order to assess the response according the GCIG-criteria (see below). Patients without elevated CA-125 may be enrolled if they show a measurable or not-measurable disease (according RECIST) evaluated by imaging techniques (measurable disease – at least one unidimensionally measurable lesion = 20 mm by conventional techniques OR = 10 mm by spiral CT scan) or histologically or cytologically confirmed relapse
- •5.ECOG Performance Status of 0 or 1
- •6.= 18 years age
- •7.No prior operation or, in case of prior operation, the patient must be recovered therefrom. The operation must be performed at least 4 weeks prior to start of study drug,
- •8.Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening
- •- Hemoglobin = 9.0 g/dl
- •- Leucocyte count ? 3.000/?l
- •- Absolut neutrophil count (ANC) ? 1.500/?l
- •- Platelet count ? 100.000/?l
- •- PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists].
- •- Total bilirubin = 1,0 times the upper limit of normal
- •- ALT and AST < 2,5 x upper limit of normal (< 5 x upper limit of normal for patients with liver involvement of their cancer); Alkaline phosphatase < 4 x ULN
- •- Calculated creatinine clearance ? 50 ml/min or serum creatinine = 1,2 x upper limit of institutional values (according to Cockcroft and Gault)
- •9.Life expectancy of at least 12 weeks
- •10.Signed and dated written informed consent before the start of specific protocol procedures.
- •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.History of cardiac disease: congestive heart failure >NYHA class 2; active coronary artery disease (CAD) or myocardial infarction within the past 6 months (MI more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled arterial hypertension with systolic blood pressure >160 mmHg or diastolic blood pressure > 90 mm Hg despite optimal treatment
- •2.Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 5 years prior to study entry
- •3.Prior radiological or clinical evidence of CNS metastases including previously treated, resected, or asymptomatic brain lesions or leptomeningeal involvement by head CT scan or MRI
- •4.Known or suspected hypersensitivity reaction to topotecan or any ingredient of topotecan or sorafenib or any ingredient of sorafenib
- •5.Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
- •6.History of HIV infection or chronic hepatitis B or C
- •7.History of organ allograft
- •8.Patients with history of colon perforation
- •9.Patients with history of colitis or neutropenia colitis
- •10.Patients with evidence or history of bleeding diathesis
- •11.Serious non healing wound, fracture or ulcer
- •12.Patients undergoing renal dialysis
- •13.Patients unable to swallow oral medications
- •14.Significant disease which, in the investigator’s opinion, would exclude the patient from the study
- •15.Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results
- •16.Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
- •17.Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent
- •18.Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
- •19.Legal incapacity or limited legal capacity
- •20.Participation in another clinical study with experimental therapy within the 30 days before start of treatment
- •21. Subjects housed in an institution on official or legal orders
- •22.Patients with prior therapy containing topotecan
- •23.Patients with prior therapy containing Avastin or other VEGFR TK1
- •24.Any other anticancer chemotherapy or immunotherapy or investiagitional drug therapy outside of this trial during the study or within 4 weeks prior to study entry.
- •25.Radiotherapy during study or within 4 weeks prior to start of study drug and prior radiotherapy of > 25% of the bone marrow (exception: palliative radiotherapy of non-target lesions or pain therapy or local bone irradiation)
- •26.Autologous bone marrow transplant or stem cell rescue within 4 months of study
研究者
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