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

NCT05665023 | Unknown Phase 2

• 1 other identifier: 4-2021-1776
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mucinous Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer

Keywords

mucinous ovarian cancer; fallopian tube cancer; primary peritoneal cancer; palliative; avastin; modified FOLFIRINOX

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Progression-free survival

  up to 1 year

• Disease control rate

  at 6 months

• Overall survival

  up to 1 year

• Number of Participants With Adverse Events (CTCAE v5.0)

  from the start to within 30 days of the final chemotherapy

• Patient reported outcomes

  at the beginning and every 4 cycles of the treatment (each cycle is 14 days), up to 1 year

Study Arms (1)

Bevacizumab + modified FOLFIRINOX

EXPERIMENTAL

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

Interventions

Bevacizumab + modified FOLFIRINOX DRUG

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

Bevacizumab + modified FOLFIRINOX

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Informed consent
• Age more than 19 years old
• Patients with measurable lesions according to RECIST v1.1.
• ECOG Performance score 0-2
• Patients with adequate organ function
• 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.
• Patients who have previously received systemic chemotherapy, including oxaliplatin or irinotecan. \*Previous treatment with bevacizumab is acceptable.
• Pregnant or breastfeeding women
• 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.
• Active central nervous system (CNS) metastases and/or carcinoma meningitis.
• Patients with known aggravation within the past 3 years or other malignant tumors requiring aggressive treatment.
• Patients with moderate acute or chronic medical conditions or abnormal findings on examination, which are judged to affect the results of this study
• 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)
• Clinically significant heart disease.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Fallopian Tube Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Min Hwan Kim

  Division of Medical Oncology, Yonsei Cancer Center, Yonsei Univ. College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Hwan Kim

CONTACT

+82-2-2228-8133; gemgoon3691@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 27, 2022
• Study Start: October 28, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2025
• Last Updated: December 29, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)