Tinzaparin And Biomarkers After Neoadjuvant Treatment of Ovarian Cancer

Ki vehet részt

• The subject has given written consent to participate in the study
• Age 18 and above
• Epithelial ovarian, fallopian tube or peritoneal cancer, or abdominal cancer where a biopsy indicates an origin from the ovary, fallopian tube or peritoneum
• Histology diagnosis of either high grade serous carcinoma, endometroid carcinoma or clear cell carcinoma
• FIGO stage III-IV disease
• Planned for platinum-based chemotherapy
• Prior to start of NACT pregnancy should be ruled out by menstrual history or in unclear cases by a urine hCG test
• Women of childbearing potential should use a safe birth control method (combined hormonal contraception, progesterone only hormonal contraception, intra uterine device, bilateral tubal occlusion, vasectomized partner, sexual abstinence, male or female condom, diaphragm with spermicide)
• WHO Performance Status 0-2
• Weight 50-150 kg
• CA-125-level ≥250 kIE/L at diagnosis

Ki nem vehet részt

• Treatment with heparins, low molecular weight heparins or non-vitamin K antagonist oral anticoagulants within the last year
• Abdominal surgery or other major surgery within the last year
• Participation or recent participation (within the last 30 days) in a clinical study with an investigational product
• Previous heparin-induced thrombocytopenia
• Known or suspected allergies against any product included in the study
• Treatment or disease which, according to the investigator, can affect treatment or study results
• Ongoing treatment of thromboembolic disease
• Thromboembolic disease within the last year
• Hypersensitivity to the active substance (tinzaparin) or any of the excipients
• Severe coagulation disorder
• Acute gastro duodenal ulcer
• Treatment for other known malignancy within the last year (except basal cell carcinoma)
• Concomitant treatment with heparins, low molecular weight heparins, warfarin or non-vitamin K antagonist oral anticoagulants. Platelet inhibitors are allowed
• Serious hemorrhage or conditions predisposing to serious hemorrhage. Serious hemorrhage is defined as fulfilling any one of these three criteria:; occurs in a critical area or organ (e.g. intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, intra-uterine or intramuscular with compartment syndrome),; causes a fall in hemoglobin level of 20 g/L (1.24 mmol/L) or more, or; leads to transfusion of two or more units of whole blood or red blood cells
• E-GFR <30ml/min (analyzed no more than 14 days before start of treatment with investigational product)
• Platelets <100 x10\^9/L (analyzed no more than 14 days before start of treatment with investigational product)
• Ongoing pregnancy, independent of gestational age. Breastfeeding or planned pregnancy
• EOC disclosed at Cesarean section
• Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
• Known brain metastasis
• Septic endocarditis
• WHO Performance Status >2