Tinzaparin And Biomarkers After Neoadjuvant Treatment of Ovarian Cancer

Summary

Background: Previous findings have indicated antineoplastic properties of tinzaparin (Innohep®), a commonly used anti-coagulant. Earlier studies have mainly investigated the antineoplastic effects of tinzaparin in animal models and in human cell-lines. In this pilot study the aim is to examine the potential antitumoral effects of tinzaparin in vivo in women with epithelial ovarian cancer (EOC). Study objectives: Primary 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 neoadjuvant chemotherapy (NACT). Secondary objectives: 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.

Eligibility

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 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

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
* Abdominal surgery or other major surgery within the last year
* 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
* Known brain metastasis
* 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:

  1. occurs in a critical area or organ (e.g. intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, intra-uterine or intramuscular 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 \>2.
* 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)
* Treatment for other known malignancy within the last year (except basal cell carcinoma)

Conditions2

Interventions1

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