EUCTR2008-004429-41-FI进行中（未招募）不适用
A Double-Blind, Randomized Phase II Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Ovarian Epithelial Cancer or Primary Peritoneal Cancer Patients who have achieved a Complete Clinical Response after Standard Platinum/Taxane Containing Chemotherapy
Bayer Healthcare AG, D-51368 Leverkusen, Germany0 个研究点目标入组 250 人开始时间: 2008年12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
- 入组人数
- 250
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
- •Patients must be able and willing to sign a written informed consent. A signed informed consent must be appropriately obtained prior to any study specific procedures.
- •Age =18 years.
- •Histologically confirmed FIGO stage III or IV ovarian epithelial cancer or primary peritoneal cancer at presentation. Patients must have achieved a clinical complete response (disappearance of all clinical and radiological evidence of tumor) after only one regimen (4-6 cycles) of platinum and taxane-based standard chemotherapy received after tumor debulkment. No previous chemotherapy can be administered except for the one regimen for ovarian or primary peritoneal cancer.
- •Normal serum CA125 level within 7 days of first dose of sorafenib.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •All scans used to document complete response must be done within 30 days prior to randomization.
- •Patients must be able to swallow and retain oral medication.
- •Life expectancy of at least 12 weeks.
- •Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
- •- Hemoglobin =8.5 g/dl
- •- Absolute neutrophil count (ANC) =1,500/mm3
- •- Platelet count = 75,000/µl
- •- Total bilirubin = 1.5 times the upper limit of normal
- •- Alanine transaminase (ALT) and Aspartate aminotransferase (AST) = 2.5 x upper limit of normal
- •- Alkaline phosphatase = 4 x upper limit of normal (ULN)
- •- Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.5 x ULN
- •- Serum creatinine = 1.5 x ULN.
- •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
- •Patients with any residual cancer tissue after the completion of chemotherapy detectable by standard CT or magnetic resonance imaging (MRI).
- •Prior local radiotherapy, neoadjuvant chemotherapy or intraperitoneal chemotherapy for any current or prior diagnosis of ovarian or primary peritoneal cancer.
- •Histologic subtypes of ovarian cancer other than epithelial (i.e. sarcoma, lymphoma, germ cell).
- •Major surgery, open biopsy, or significant traumatic injury within 30 days prior to randomization.
- •Non-healing wound, ulcer, or bone fracture.
- •Evidence or history of bleeding diathesis or coagulopathy.
- •Clinically significant cardiac disease including congestive heart failure > class II New York Heart Association (NYHA), unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months) or myocardial infarction within the past 6 months prior to randomization.
- •Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy or uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg) despite optimal medical management.
- •Thrombotic or embolic venous or arterial events, such as a cerebrovascular accident, including transient ischemic attacks and pulmonary embolism within the past 6 months.
- •Hemorrhage/bleeding event = NCI-Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 within 30 days of randomization.
- •Infection > NCI-CTCAE Grade 2.
- •Known human immunodeficiency virus infection or infection with hepatitis B or C.
- •Previous or concurrent cancer that is distinct in primary site or histology from ovarian or primary peritoneal cancer within 5 years prior to randomization EXCEPT cervical cancer in situ, treated basal cell carcinoma and superficial bladder tumors [Ta (Non invasive tumor), Tis (Carcinoma in situ) and T1 (Tumor invades lamina propria)].
- •Known or suspected allergy to sorafenib or hypersensitivity to sorafenib or any agent given in the course of this trial.
- •Patients with seizure disorder requiring medication (such as steroids or anti-epileptics).
- •Patients undergoing renal dialysis.
- •Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results.
- •Unresolved toxicity (i.e. neurotoxicity) attributed to the required chemotherapy higher than NCI-CTCAE (version 3) Grade 2 (excluding cases of alopecia).
- •Patients unable to swallow oral medications.
- •Any malabsorption condition.
- •Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
- •Known brain metastasis. Patients with unexplained neurological symptoms will undergo a CT scan/MRI of the brain to exclude brain metastasis.
研究者
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