Epithelial ovarian cancer
Conditions
Interventions
Trade Name: Innohep
Product Name: Innohep
Pharmaceutical Form: Solution for injection
Sponsors
Region Östergötland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subject has given written consent to participate in the study. Female sex Age 18 and above Epithelial ovarian, fallopian tube or peritoneal cancer, or abdominal cancer where a biopsy or cytology 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. Selected for NACT with platinum double regimen at a multidisciplinary conference at Department of Oncology at Linköping University Hospital Receive treatment at either of the University Hospital in Linköping, or the hospitals in Jönköping (Ryhov Hospital), Eksjö (Höglandssjukhuset Eksjö), Västervik (Västervik sjukhus), Kalmar (Länssjukhuset i Kalmar), Värnamo (Värnamo sjukhus). Planned for platinum doublet regimen. 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 0-1 Weight 50-150 kg CA-125-level =250 kIE/L before start of treatment 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 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: Concomitant treatment with heparins, low molecular weight heparins, warfarin or non-vitamin K antagonist oral anticoagulants. Platelet inhibitors are allowed. Treatment with heparins, low molecular weight heparins or non-vitamin K antagonist oral anticoagulants within the last year. Known or suspected allergies against any product included in the study 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 Treatment or disease which, according to the investigator, can affect treatment or study results Participation or recent participation (within the last 30 days) in a clinical study with 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. Serious hemorrhage is defined as fulfilling any one of these three criteria: a) occurs in a critical area or organ (e.g. intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, intra-uterine or intramuscular with compartment syndrome), b) causes a fall in hemoglobin level of 20 g/L (1.24 mmol/L) or more, or c) 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 E-GFR <30ml/min (analyzed no more than 14 days before start of treatment with investigational product) Platelets <50 x10^9/L (analyzed no more than 14 days before start of treatment with investigational product) Other known malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the effects of tinzaparin on changes in levels of CA-125 in EOC patients who receive NACT.;Secondary Objective: The secondary objective of the study is to explore the impact of tinzaparin on the dynamic of a spectrum of immunological and coagulation factors in EOC patients who receive NACT. Besides, the compliance of tinzaparin injections and adverse events caused by tinzaparin will be described and any thromboembolic events will be registered.;Primary end point(s): Level of CA-125.;Timepoint(s) of evaluation of this end point: Week 1,4,7,10 and week 13/14. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A, Levels of hemoglobin, platelets, leucocytes, CRP, albumin, IL-6 and VEGF B, CA-125 C, The compliance to tinzaparin injections and occurrence of adverse events related to tinzaparin will be determined. D, Objectively confirmed VTE, i.e. pulmonary embolism, lower-limb deep vein thrombosis or upper extremity deep vein thrombosis. Death due to VTE. ;Timepoint(s) of evaluation of this end point: A, Week 1,4,7,10, 13/14, 16/17, 19/20 and 22/23. b, Week 13/14, 16/17, 19/20 and 22/23. c, Continously d, Continously | — |
Countries
Sweden
Contacts
Public ContactPreben Kjølhede
Region Östergötland
Outcome results
None listed