EUCTR2006-004644-24-DE进行中（未招募）不适用
Prospective, open label, multi center phase II clinical trial with neoadjuvant chemotherapy in addition with Sorafenib in patients with primarily advanced ovarian cancer (FIGO IIIC + IV) and ascites (>500ml) - primofenib-07
niversity of Bonn0 个研究点目标入组 102 人开始时间: 2007年4月13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
- 102
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
- •oWritten informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw the consent without the need to specify a respective reason
- •oHistological confirmed primary epithelial ovarian cancer carcinoma of the fallopian tubes and extra ovarian peritoneal carcinoma stage FIGO IIIC or IV, verified by laparoscopy or laparotomy
- •oMore than 500 ml ascites (verified by ultrasound or ct-scan)
- •oFemale patients with age higher or equal to 18 years
- •oLife expectancy of at least 12 weeks
- •oPatients who have an ECOG performance status of less or equal 2
- •oAdequate bone marrow, renal and hepatic function, assessed by the following laboratory investigations at screening:
- •oHemoglobin = 8 g/dl
- •oAbsolute neutrophile count ? 1,500/ mm³
- •oThrombocytes? 100,000/ µl
- •oBilirubine total? 1,5 x ULN
- •oALT and AST? 2,5 x ULN
- •oAlkaline phosphatase (AP)? 6.0 x ULN
- •oSerum creatinine? 1,5 x ULN
- •oEstimated GFR (by Jeliffe)? 60 ml / min
- •oAmylase and lipase? 1.5 x ULN
- •oPT or INR and PTT? 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
- •oPatients with a history of other malignancies during the past 3 years, with the exception of adequately treated basal or squamous-cell skin cancer, or cervical carcinoma
- •oMajor surgery within 4 weeks of enrolment, or major debulking surgery without any time limit
- •oPatients with symptoms of ileus
- •oKnown history of HIV infection or chronic hepatitis B or C infection
- •oActive serious bacterial or fungal infections (> grade 2 NCI-CTCAE, Version 3.0)
- •oHistory of cardiac disease: congestive heart failure >NYHA class 2, active CAD (coronary artery disease) (MI more than 6 months prior to study entry is allowed); cardiac arrhythmia requiring and arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension
- •oPatients undergoing renal dialysis
- •oPatients with evidence or history of bleeding diathesis
- •oHistory of motorial and sensorial neuropathic disorders equal or higher than grade 2
- •oKnown neoplastic central nervous system abnormality. Patients with neurological symptoms should undergo CT scan/MRI of the brain to exclude brain metastasis
- •oManifest depression
- •oKnown or suspected allergy to the investigational agent or any agent given in association with this trial
- •oPatients with seizure disorder requiring medication
- •oHistory of organ allograft
- •oSubstance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study
- •oPregnant or breastfeeding patients: Women with childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of the study drug
- •oPatients enrolled in this trial must use adequate barrier contraceptive measures during the course of the trial until hysterectomy in ‘Debulking surgery’ was performed
- •oAny prior systemic anticancer therapy including chemotherapy, targeted agents, experimental therapy, endocrine therapy radiotherapy or biological therapy
- •oConcurrent anticancer chemotherapy or immunotherapy.
- •oConcurrent treatment with systemic corticosteroids, except antiemetic.
- •oInvestigational drug therapy outside of this trial during or within 4 weeks of study entry
- •oPatients receiving immunotherapy, radiation therapy, chemotherapy, or other investigational agents within 30 days prior to the first study drug administration
- •oPatients unable to swallow oral medications
- •oConcomitant administration of:
- •oRifampicin
- •oSt. John´s Wort (hypericum perforatum; DE: Johanniskraut)
研究者
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