Epithelial Ovarian Cancer, Fallopian Tube Cancer and Primary Peritoneal Cancer
Conditions
Interventions
None listed
Sponsors
Japanese Gynecologic Oncology Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. 1) Patient diagnosed with a stageIII-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer in a primary surgery and expected to receive the first-line chemoterapy 2) Patient histologocally diagnosed with stageIII-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer and expected to receive the first post-operative chemoterapy after interval debulking surgery after neoadjuvant chemotherapy 2. Patient expected to receive combination therapy with bevacizumab and platinum based chemotherapy (iv) and consented to receive the treatment 3. Age: 20 or older at registration 4. No primary surgery or interval debulking surgery within 28 days prior to the study treatment 5. ECOG Performance Status: 0-2 6. Adequate bone marrow and organ function 7. No limitation is required with presence or absence of measurable lesions. 8.Patient expected to survive longer than 3 months 9.Patient can comply with the protocol. 10. Patient must have signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Patient who has received bevacizumab infusion 2.Patient with perforation of the digestive tract and severe fistula at registration 3.Patient with a history of hypersensitivity to the drug used in combination to bevacizumab 4.Patient with a history of hemoptysis (hemoptysis of fresh blood of 2.5ml or more) 5.Patient with a history of abdominal radiation therapy 6. Patient with active infection at registration 7. Pregnancy or during breast feeding or a patient willing to be pregnant 8. Patient with uncontrolled hypertension at registration 9.Patient suspected or diagnosed as arterial thromboembolism (cerebral infarction, myocardial infarction, etc.) at registration 10.Patient suspected or diagnosed as venous thromboembolism (deep vein thrombosis, pulmonary embolism, etc.) at registration 11.Patient of 2 + or more proteinuria at registration 12.Patient who is judged inappropriate to participate in this study by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expression rate of the following adverse events in patients with tri-weekly paclitaxel and carboplatin plus bevacizumab *Bevacizumab-specific adverse events *Other Adverse events of Grade 3 or more | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival and response rate in patients with tri-weekly paclitaxel and carboplatin plus bevacizumab | — |
Countries
Japan
Contacts
Public ContactShinichi Komiyama ,M.D.,Ph.D.
Toho University Ohashi Medical Center Department of Obsterics and Gynecology
Outcome results
None listed