Advanced FIGO Stage IIIB-IV High Grade Serous or Endometrioid Ovarian,Fallopian Tube, or Peritoneal Cancer
Conditions
Interventions
Olaparib tablets per os 300 mg twice daily
Placebo tablets per os 300 mg twice daily
Sponsors
GOTIC
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Signed informed consent and ability to comply with treatment and follow-up. 2. Patient with newly diagnosed, Ovarian cancer, primary peritoneal cancer and/or fallopian-tube cancer, Histologically confirmed high grade serous or high grade endometrioid or other epithelial non mucinous ovarian cancer in a patient with germline BRCA 1 or 2 deleterious mutation, at an advanced stage: FIGO stage IIIB, IIIC, or IV of the 1988 FIGO classification. 3. Patient who has completed prior to randomization first line platinum-taxane chemotherapy. 4. Patient must have received prior to randomization a minimum of 3 cycles of bevacizumab in combination with the 3 last cycles of platinum-based chemotherapy. Bevacizumab treatment should be administered at a dose 15mg/kg q3 weeks up to a total of 15 months. 5. Patient must be prior to randomization without NED or in CR or PR from her first line treatment. There should be no clinical evidence of disease progression throughout her first line treatment and prior to study randomization. 6. Patient must be randomized at least 3 weeks and no more than 9 weeks after her last dose of chemotherapy (last dose is the day of the last infusion) and all major toxicities from the previous chemotherapy must have resolved to CTC AE grade 1 or better. 7. Patient must have normal organ and bone marrow function. 8. ECOG performance status 0-1. 9. Formalin fixed, paraffin embedded tumor sample from the primary cancer must be available for central BRCA testing and test result must be available for stratification. 10. Postmenopausal or evidence of non-childbearing status for women of childbearing potential prior to the first dose of study treatment.
Exclusion criteria
Exclusion criteria: 1. Non-epithelial origin of the ovary, the fallopian tube or the peritoneum 2. Ovarian tumors of low malignant potential (e.g. borderline tumors), or mucinous carcinoma. 3. Patient with synchronous primary endometrial cancer unless both of the following criteria are met: stage < II, Less than 60 years old at the time of diagnosis of endometrial cancer with stage IA or IB grade 1 or 2, or stage IA grade III endometrioid adenocarcinoma OR over 60 years old at the time of diagnosis of endometrial cancer with stage IA grade 1 or 2 endometrioid adenocarcinoma. 4. Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS). Patient with a history of localized malignancy diagnosed over 5 years ago may be eligible provided she completed her adjuvant systemic therapy prior to randomization and that the patient remains free of recurrent or metastatic disease. Patient with history of primary triple negative breast cancer may be eligible provided she completed her definitive anticancer treatment more than 3 years ago and she remains breast cancer disease free prior to start of study treatment. 5. Patient with myelodysplastic syndrome/acute myeloid leukemia history. 6. Patient having experienced for at least one cycle, a delay > 2 weeks due to prolonged hematological recovery during the first line chemotherapy. 7. Patient receiving radiotherapy within 6 weeks prior to study treatment. 8. Major surgery within 4 weeks of starting study treatment and patient must have recovered from any effects of any major surgery. 9. Previous allergenic bone marrow transplant. 10. Any previous treatment with PARP inhibitor, including olaparib. et cetera
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is progression-free survival (PFS1) defined as the time from the date of randomization to the first documented disease progression (according to RECIST v1.1) or death from any cause, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine : #1 time to earliest progression by RECIST or Cancer Antigen-125 (CA-125) or death #2 time from randomization to first subsequent therapy or death (TFST) #3 time from randomization to second progression (PFS2) #4 time from randomization to second subsequent therapy or death (TSST) #5 overall survival (OS) 2. To assess the safety and tolerability of olaparib maintenance compared to placebo. 3. To compare the effects of olaparib maintenance compared to placebo on Health-Related Quality of Life (HRQoL) and patient reported outcomes (PROs), with consideration of patient preference. 4. To evaluate the impact of treatment and disease on resource use. | — |
Countries
Japan,Europe
Contacts
Public ContactKeiichi Fujiwara
Saitama Medical University International Medical Center Department of Gynecologic Oncology
Outcome results
None listed