ovarian cancer
Conditions
Interventions
Patients will be included after surgery and will be randomized after cycle 1 (carboplatin AUC 5-6 + paclitaxel 175 mg/m2), using an Interactive Voice Response System / Interactive Web Response System
Sponsors
Hasegawa Kosei
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female patient >= 18 years of age. 2. Signed informed consent and ability to comply with treatment and follow-up. 3. Patient with newly diagnosed, a. Ovarian cancer, primary peritoneal cancer and/or fallopian-tube cancer, b. Histologically confirmed (based on local histopathological findings): - high grade serous or - high grade endometrioid (grade 2 and 3) or - other epithelial non mucinous and non-clear cell ovarian cancer in a patient with germline BRCA1 or 2 deleterious mutation c. At an advanced stage: FIGO stage IIIA to IIIC of the 2018 FIGO classification. 4. Patient having undergone frontline, complete cytoreductive surgery (i.e. no visible residual disease): The patient will be considered eligible once the ESGO Quality Assurance in Ovarian Cancer Surgery will have been filled out and validated. 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 6. Patient must have received one cycle of carboplatin AUC 5-6 + paclitaxel 175 mg/m2. 7. Patient must start cycle 1 chemotherapy no later than 6 weeks after surgery. 8. Patient must have a thorax-abdomen-pelvis CT scan between surgery and Cycle1, with no evidence of disease. 9. Patient eligible for first line platinum-taxane chemotherapy. 10. Patient eligible for bevacizumab treatment in combination with chemotherapy and in maintenance. It must be started at the second chemotherapy cycle and be administered at a dose of 15mg/kg every 3 weeks up to a total of 15 months. 11. Patient must have normal organ and bone marrow function before first cycle of chemotherapy: - Hemoglobin >= 9.0 g/dL. - Absolute neutrophil count (ANC) >= 1.5 x 109/L. - Platelet count >= 100 x 109/L. - Total bilirubin = 30 mL/min, by using an exact measure (ie. Iohexol clearance) or the most appropriate formula (Jeliffe, Cockroft Gault, MDRD, CKD-EPI) to the investigator s discretion. - Patient not receiving anticoagulant medication who has an International Normalized Ratio (INR) >=1.5 and an Activated ProThrombin Time (aPTT) >=1.5 x ULN. The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or APTT is within therapeutic limits (according to site medical standard). If the patient is on oral anticoagulants, dose has to be stable for at least two weeks at the time of randomization. 12. Urine dipstick for proteinuria =2+, 24-hour proteinuria must be <1g. 13. Normal blood pressure or adequately treated and controlled hypertension (systolic BP =< 140 mmHg and/or diastolic BP =< 90 mmHg). 14. Formalin fixed paraffin embedded (FFPE) tumor sample from the primary cancer must be available for local BRCA testing and if possible HRD testing (optional). 15. For countries where this will apply to: a subject will be eligible for randomization in this study only if either affiliated to, or a beneficiary of, a social security category.
Exclusion criteria
Exclusion criteria: 1. Patient with clear cell adenocarcinoma or carcinosarcoma, non-epithelial origin of the ovarian tumor, the fallopian tube or the peritoneal tumor (i.e. germ cell tumors). 2. Ovarian tumor of low malignant potential (e.g. borderline tumor), or mucinous carcinoma. 3. Patient with a diagnosis, detection, or treatment of another type of cancer = 325 mg/day. 11. Prior history of hypertensive crisis (CTC-AE grade 4) or hypertensive encephalopathy. 12. Clinically significant (e.g. active) cardiovascular disease, including: - Myocardial infarction or unstable angina within == grade 2 congestive heart failure (CHF), - Poorly controlled cardiac arrhythmia despite medication (patient with rate controlled atrial fibrillation are eligible), or any clinically significant abnormal finding on resting ECG. - Peripheral vascular disease grade >= 3 (e.g. symptomatic and interfering with activities of daily living [ADL] requiring repair or revision). 13. Previous Cerebro-Vascular Accident (CVA), Transient Ischemic Attack (TIA), Sub- Arachnoids Hemorrhage (SAH) or Posterior Reversible Encephalopathy Syndrome (PRES). 14. History or evidence of hemorrhagic disorders. 15. Evidence of bleeding diathesis or significant coagulopathy (in the absence of coagulation). 16. History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI of the brain is mandatory (within 4 weeks prior to randomization) in case of suspected brain metastases. Spinal MRI is mandatory (within 4 weeks prior to randomization) in case of suspected spinal cord compression. 17. History or evidence upon neurological examination of central nervous system (CNS) disease, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures). 18. Significant traumatic injury during 4 weeks prior to randomization. 19. Non-healing wound, active ulcer, or bone fracture. Patient with granulating incisions healing by secondary intention with no evidence of facial dehiscence or infection is eligible but require 3 weekly wound examinations. 20. History of VEGF therapy related abdominal fistula or gastrointestinal perforation or active gastrointestinal bleeding within 6 months prior to the first study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival rate at 24 months | — |
Countries
Belgium, France, Italy, Japan, Koria, Spain
Contacts
Public ContactClinical Trial Coordinating Office
CMIC Co., Ltd.
Outcome results
None listed