A Phase 2 interventional study of Bevacizumab + modified FOLFIRINOX in Mucinous Ovarian Cancer, Fallopian Tube Cancer and Primary Peritoneal Cancer, sponsored by Yonsei University. Status unknown at 1 site in Korea, Republic of. Open to female participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-12-29.
Sponsored by Yonsei University · Phase 2, Interventional, and Treatment
This research study is evaluating a modified FOLFIRINOX plus bevacizumab therapy for mucinous ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.
This study is aimed at recurrent/metastatic/resectable patients who have received systemic chemotherapy of 2nd line or less. Excludes previously diagnosed mucinous tumors of gastrointestinal origin through upper and lower endoscopy and pathologic immunohistochemical staining.
Bevacizumab plus modified FOLFIRINOX drug is administered every 2 weeks. To prevent neutropenia fever during chemotherapy, pegteograstim is given 24 hours after chemotherapy.
The primary objective of this study is the objective response rate (ORR). The secondary objectives are progression-free survival (PFS) and disease control rate at 6 months after administration, disease control rate (DCR), overall survival (OS), drug safety, and quality of life improvement as assessed by patient questionnaires.
In addition, the investigators intend to explore biomarkers that can predict the effect of bevacizumab + mFOLFIRINOX combination therapy through the collection of tumor samples and blood samples for exploratory purposes.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's planned enrollment of 37 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with recurrent, metastatic, or unresectable ovarian cancer, fallopian tube cancer, or primary peritoneal cancer diagnosed cytologically or histologically as mucinous cancer.
*Subjects who are metastatic (stage IV) or mucinous ovarian cancer that cannot be surgically resected at diagnosis may have undergone cytoreductive surgery prior to systemic chemotherapy. It is appropriate for participation in this study if there are residual lesions after surgery and other selection criteria are met.
Patients who have not received previous systemic chemotherapy for recurrent, metastatic, or unresectable ovarian, fallopian tube, or primary peritoneal cancer, or who have failed second-line or less systemic chemotherapy. However, immunotherapy alone (eg, anti-PD-1 or anti-PD-L1 immunotherapy) is not included in previous chemotherapy.
*Platinum susceptibility does not affect the selection/exclusion criteria for this trial.
Exclusion Criteria:
Bevacizumab 5mg/kg D1, oxaliplatin 85 mg/m2 D1 + leucovorin 400mg/m2 D1 + irinotecan 150 mg/m2 D1 + 5-FU 2,400 mg/m2 46h continuous infusion, every other week
Drug: Bevacizumab + modified FOLFIRINOX
Bevacizumab 5mg/kg D1, oxaliplatin 85 mg/m2 D1 + leucovorin 400mg/m2 D1 + irinotecan 150 mg/m2 D1 + 5-FU 2,400 mg/m2 46h continuous infusion, every other week
Objective response rate
Objective response rate assessed using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) for Intention-to-treatment group
Time frame: up to 1 year
Progression-free survival
Progression-free survival assessed using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) and Kaplan-Meier Survival analysis
Time frame: up to 1 year
Disease control rate
Disease control rate assessed using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) for Intention-to-treatment group
Time frame: at 6 months
Overall survival
Overall survival assessed using Kaplan-Meier Survival analysis to check survival outcomes of Intention-to-treatment group
Time frame: up to 1 year
Number of Participants With Adverse Events (CTCAE v5.0)
Safety profiles assessed using Common Terminology Criteria for Adverse Events v5.0 (CTCAE v5.0)
Time frame: from the start to within 30 days of the final chemotherapy
Patient reported outcomes
Patient reported outcomes assessed using EQ-5D
Time frame: at the beginning and every 4 cycles of the treatment (each cycle is 14 days), up to 1 year
Patient reported outcomes
Patient reported outcomes assessed using EORTC QLQ-CIPN20
Time frame: at the beginning and every 4 cycles of the treatment (each cycle is 14 days), up to 1 year
Febrile neutropenia prevention efficacy and safety profiles of Pegteograstim
Pegteograstim efficacy and safety profiles assessed using Common Terminology Criteria for Adverse Events v5.0 (CTCAE v5.0)
Time frame: from the start to within 30 days of the final chemotherapy
Plan to share: No
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This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Yonsei University