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

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

Study Overview

• Status: Recruiting
• Conditions: Fallopian Tube Cancer; Primary Peritoneal Cancer; Mucinous Ovarian Cancer
• Intervention / Treatment: Drug: Bevacizumab + modified FOLFIRINOX

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 Type: Interventional
• Enrollment (Anticipated): 37
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Min Hwan Kim; Phone Number: +82-2-2228-8133; Email: gemgoon3691@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Yonsei University Health System, Severance Hospital
    • Contact: Min Hwan Kim; Phone Number: +82-2-2228-8133; Email: gemgoon3691@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	Progression-free survival assessed using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) and Kaplan-Meier Survival analysis	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	at 6 months
Overall survival	Overall survival assessed using Kaplan-Meier Survival analysis to check survival outcomes of Intention-to-treatment group	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)	from the start to within 30 days of the final chemotherapy
Patient reported outcomes	Patient reported outcomes assessed using EQ-5D	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	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)	from the start to within 30 days of the final chemotherapy

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Min Hwan Kim, Division of Medical Oncology, Yonsei Cancer Center, Yonsei Univ. College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2022
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): February 1, 2025

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: December 23, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Estimate): December 29, 2022
• Last Update Submitted That Met QC Criteria: December 25, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: avastin; fallopian tube cancer; primary peritoneal cancer; palliative; modified FOLFIRINOX; mucinous ovarian cancer
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Fallopian Tube Diseases; Neoplasms, Cystic, Mucinous, and Serous; Ovarian Neoplasms; Fallopian Tube Neoplasms; Adenocarcinoma, Mucinous; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab; Folfirinox
• Other Study ID Numbers: 4-2021-1776

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No