EUCTR2008-004429-41-IT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 - ND
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
- 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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