Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: Drug: Following randomization,
in Arm A- Oral Apixaban 2.5 mg twice daily (12 hourly) through the course of neoadjuvant chemotherapy.
Drug to be started within 24 hours of commencemen
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1) All women histologically diagnosed with advanced stage ovarian cancer (FIGO Stage III/IV) triaged to receive neoadjuvant chemotherapy 2) = 18 years age 3) ECOG performance status 0-3 4) Adequate renal function: Serum Creatinine levels 0.5 to 1.1 mg/dL 5) Khorana score =2 6) Be able to provide informed consent and sign an informed consent document
Exclusion criteria
Exclusion criteria: 1. Previously diagnosed/treated VTE 2. Evidence of VTE on screening duplex compression ultrasonography or incidental VTE identified on CT scans ordered primarily for staging of malignancy prior to randomization 3. History of malignancies of other than ovarian origin 4. Known brain metastases 5. Bleeding diathesis, hemorrhagic lesions, hemorrhagic cerebrovascular accident, active bleeding, and other conditions with a high risk for bleeding 6. Diagnosed significant liver disease or dysfunction, as defined by liver function test (LFT) abnormalities 7. PLatelet count less than 100,000/mm3 8. Deranged kidney function Concomitant use of anticoagulation therapy for prior VTE or other indications with either LMWH, warfarin, or direct oral anti- anticoagulants 9. Dual anti-platelet therapy, daily non- steroidal anti-inflammatory drugs, or other medications known to increase the risk of bleeding (a daily dose of =100 mg of aspirin and single agent clopidogrel are allowed) 10. Known allergies, hypersensitivity, or intolerance to Apixaban or its excipients 11. Pregnant or breast-feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with VTE events in patients receiving Apixaban versus group receiving standard of careTimepoint: The number and time points of VTE events will be categorized into one of the following periods: i. At diagnosis of advanced epithelial ovarian cancer, at baseline ii. Before administration of NACT, at week 1 iii. Following NACT completion and prior to interval cytoreductive surgery, at week 9 iv. Post interval cytoreductive surgery, or prior to adjuvant chemotherapy, at week 16 v. Post cytoreductive surgery, at Day 180/ week 40 | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients with interruption in chemotherapy treatment, delay in cytoreductive surgery, morbidity & mortality ? Number of patients with adverse events due to ApixabanTimepoint: The number & time points of VTE events will be categorized into one of the following periods: i. At diagnosis of advanced epithelial ovarian cancer, at baseline ii. Before administration of NACT, at week 1 iii. Following NACT completion & prior to interval cytoreductive surgery, at week 9 iv. Post interval cytoreductive surgery, or prior to adjuvant chemotherapy, at week 16 v. Post cytoreductive surgery, at Day 180/ week 40 | — |
Countries
India
Contacts
Public ContactDr Anju Singh
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed