Tinzaparin treatment for women with advanced ovarian cancer receiving chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot trial investigates the potential antitumoral effects of tinzaparin, an anticoagulant, in women with epithelial ovarian cancer (EOC) undergoing neoadjuvant chemotherapy. Participants will be randomly assigned to receive either tinzaparin or no treatment while receiving standard chemotherapy with carboplatin and paclitaxel. The study aims to evaluate changes in cancer biomarker CA-125 and assess various immunological and coagulation factors throughout the treatment process. Blood samples will be collected at multiple points to analyze the effects of tinzaparin on these parameters.

Why it matters

Who can join: the full rules

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)

Where it's running

• Department of Obstetrics and Gynecology, Highland Hospital
  Eksjö, Eksjö, Sweden Recruiting
• Department of Oncology, Sahlgrenska University Hospital
  Gothenburg, Gothenburg, Sweden Recruiting
• Department of Obstetrics and Gynecology, Ryhov County Hospital
  Jönköping, Jönköping County, Sweden Recruiting
• Department of Oncology, Linköping University Hospital
  Linköping, Linköping, Sweden Recruiting
• Department of Obstetrics and Gynaecology, Norrland University Hospital
  Umeå, Umeå, Sweden Recruiting
• Department of Obstetrics and Gynecology, Värnamo Hospital
  Värnamo, Värnamo, Sweden Recruiting

Study contacts

• Study coordinator: Preben Kjölhede, MD, PhD
• Email: preben.kjolhede@regionostergotland.se
• Phone: +46101030000

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.