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

Phase 2

Recruiting

• Conditions: Primary Peritoneal Cancer; Mucinous Ovarian Cancer; Fallopian Tube Cancer
• Interventions: Drug: Bevacizumab + modified FOLFIRINOX

• Registration Number: NCT05665023
• Lead Sponsor: Yonsei University

Brief 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.

Study Timeline

• Study Start: 2022-10-28
• Study First Submitted: 2022-11-15
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-23
• Last Update Submitted: 2022-12-25
• Study First Posted: 2022-12-27
• Last Update Posted: 2022-12-29
• Primary Completion: 2024-02-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 37

Inclusion Criteria

1. 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.

2. Mucous tumors of gastrointestinal origin should be excluded by prior upper and lower intestinal endoscopy and pathologic immunohistochemical staining (CEA, SATB2, etc.).

3. 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.

4. Informed consent

5. Age more than 19 years old

6. Patients with measurable lesions according to RECIST v1.1.

7. ECOG Performance score 0-2

8. Patients with adequate organ function

9. Women of childbearing potential must either have a negative pregnancy test on a urine or serological test or consent to the use of an appropriate contraceptive method.

Exclusion Criteria

1. Patients who have previously received systemic chemotherapy, including oxaliplatin or irinotecan. *Previous treatment with bevacizumab is acceptable.
2. Pregnant or breastfeeding women
3. Patients who received chemotherapy, targeted small-molecule agents, or radiotherapy within 2 weeks prior to Day 1 of the study, or who have not yet recovered (Grade 1 or lower or baseline level) from a previously administered drug-induced adverse event.
4. Active central nervous system (CNS) metastases and/or carcinoma meningitis.
5. Patients with known aggravation within the past 3 years or other malignant tumors requiring aggressive treatment.
6. Patients with moderate acute or chronic medical conditions or abnormal findings on examination, which are judged to affect the results of this study
7. Infected with Human Immunodeficiency Virus (HIV) (HIV-1/2 antibody) infection or active hepatitis B (HBsAg positive and HBV DNA ≥100 copies/ml) or hepatitis C (anti-HCV antibody positive and HCV RNA detected) being)
8. Clinically significant heart disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bevacizumab + modified FOLFIRINOX	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

Primary Outcome Measures

Name	Time	Method
Objective response rate	up to 1 year	Objective response rate assessed using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) for Intention-to-treatment group

Secondary Outcome Measures

Name	Time	Method
Febrile neutropenia prevention efficacy and safety profiles of Pegteograstim	from the start to within 30 days of the final chemotherapy	Pegteograstim efficacy and safety profiles assessed using Common Terminology Criteria for Adverse Events v5.0 (CTCAE v5.0)
Number of Participants With Adverse Events (CTCAE v5.0)	from the start to within 30 days of the final chemotherapy	Safety profiles assessed using Common Terminology Criteria for Adverse Events v5.0 (CTCAE v5.0)
Progression-free survival	up to 1 year	Progression-free survival assessed using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) and Kaplan-Meier Survival analysis
Overall survival	up to 1 year	Overall survival assessed using Kaplan-Meier Survival analysis to check survival outcomes of Intention-to-treatment group
Disease control rate	at 6 months	Disease control rate assessed using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) for Intention-to-treatment group
Patient reported outcomes	at the beginning and every 4 cycles of the treatment (each cycle is 14 days), up to 1 year	Patient reported outcomes assessed using EORTC QLQ-CIPN20

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of