Tinzaparin treatment for women with advanced ovarian cancer receiving chemotherapy
The Effect of Tinzaparin on Biomarkers in FIGO Stage III-IV Ovarian Cancer Patients Undergoing Neoadjuvant Chemotherapy - A Randomized Pilot Study
This study is testing whether the blood thinner tinzaparin can help women with advanced ovarian cancer feel better while they are getting chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Linkoeping Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 8 sites (Eksjö, Eksjö and 7 other locations) |
| Trial ID | NCT05284552 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with FIGO stage III-IV epithelial ovarian cancer selected for neoadjuvant chemotherapy.
Not a fit: Patients with signs of thromboembolic disease or those currently undergoing treatment for such conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel treatment option that enhances the effectiveness of chemotherapy in advanced ovarian cancer patients.
How similar studies have performed: While previous studies have explored the antineoplastic effects of tinzaparin in animal models and cell lines, this approach in humans is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Eksjö, Eksjö and 7 other locations
- 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)
- Department of Obstetrics and Gynecology, Västervik Hospital — Västervik, Västervik, Sweden (Recruiting)
- Department of Obstetrics and Gynecology, University Hospital — Linköping, Östergötland County, Sweden (Active_not_recruiting)
Study contacts
- Study coordinator: Preben Kjölhede, MD, PhD
- Email: preben.kjolhede@regionostergotland.se
- Phone: +46101030000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.