NCT05665023

Bevacizumab Plus Modiifed FOLFIRINOX in Ovarian, Fallopian Tube, or Primary Peritoneal Mucinous Carcinoma

Single-arm Phase II Study of Bevacizumab Plus Modified FOLFIRINOX Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Mucinous Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This research study is evaluating a modified FOLFIRINOX plus bevacizumab therapy for mucinous ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.

Detailed description

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.

Conditions

• Mucinous Ovarian Cancer
• Fallopian Tube Cancer
• Primary Peritoneal Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-10-28
• Primary completion: 2024-02-01
• Completion: 2025-02-01
• First posted: 2022-12-27
• Last updated: 2022-12-29

Locations

1 site across 1 country: South Korea