Tinzaparin And Biomarkers After Neoadjuvant Treatment of Ovarian Cancer

Inclusion Criteria:

• 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 abiopsy indicates an origin from the ovary, fallopian tube or peritoneum.

• Histology diagnosis of either high grade serous carcinoma, endometrioid carcinoma orclear cell carcinoma.

• FIGO stage III-IV disease.

• Selected for NACT with platinum double regimen at a multidisciplinary conference atDepartment of Oncology at Linköping University Hospital

• Receive treatment at either of the University Hospital in Linköping, or thehospitals in Jönköping (Ryhov Hospital), Eksjö (Highland Hospital, Eksjö), Västervik (Västervik hospital), Kalmar (County Hospital, Kalmar), Värnamo (Värnamo hospital).

• Planned for platinum doublet regimen.

• Prior to start of NACT pregnancy should be ruled out by menstrual history or inunclear cases by a urine human chorionic gonadotropin (hCG) test.

• Women of childbearing potential should use a safe birth control method (combinedhormonal contraception, progesterone only hormonal contraception, intra uterinedevice, bilateral tubal occlusion, vasectomized partner, sexual abstinence, male orfemale condom, diaphragm with spermicide).

• World Health Organization (WHO) Performance Status 0-1

• Weight 50-150 kg

• CA-125-level ≥250 kIU/L at diagnosis

Exclusion Criteria:

• Concomitant treatment with heparins, low molecular weight heparins, warfarin ornonvitamin K antagonist oral anticoagulants. Platelet inhibitors are allowed.

• Treatment with heparins, low molecular weight heparins or non-vitamin K antagonistoral anticoagulants within the last year.

• Known or suspected allergies against any product included in the study

• Ongoing pregnancy, independent of gestational age. Breastfeeding or plannedpregnancy

• EOC disclosed at Cesarean section

• Abdominal surgery or other major surgery within the last year

• Mental inability, reluctance or language difficulties that result in difficultyunderstanding the meaning of study participation

• Treatment or disease which, according to the investigator, can affect treatment orstudy results

• Known brain metastasis

• Participation or recent participation (within the last 30 days) in a clinical studywith an investigational product

• Ongoing treatment of thromboembolic disease.

• Thromboembolic disease within the last year.

• Hypersensitivity to the active substance (tinzaparin) or any of the excipients.

• Serious hemorrhage or conditions predisposing to serious hemorrhage. Serioushemorrhage is defined as fulfilling any one of these three criteria:

1. occurs in a critical area or organ (e.g. intracranial, intraspinal,intraocular, retroperitoneal, intra-articular or pericardial, intra-uterine orintramuscular with compartment syndrome),

2. causes a fall in hemoglobin level of 20 g/L (1.24 mmol/L) or more, or

3. leads to transfusion of two or more units of whole blood or red blood cells.

• Severe coagulation disorder.

• Acute gastro duodenal ulcer.

• Septic endocarditis.

• Previous heparin-induced thrombocytopenia.

• WHO Performance Status >1.

• Platinum single regimen

• Estimated glomerular filtration rate (E-GFR) <30ml/min (analyzed no more than 14days before start of treatment with investigational product)

• Platelets <100 x10^9/L (analyzed no more than 14 days before start of treatment withinvestigational product)

• Treatment for other known malignancy within the last year (except basal cellcarcinoma)