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

Primary Purpose

Mucinous Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer

Status
Recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Bevacizumab + modified FOLFIRINOX
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mucinous Ovarian Cancer focused on measuring mucinous ovarian cancer, fallopian tube cancer, primary peritoneal cancer, palliative, avastin, modified FOLFIRINOX

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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. *Platinum susceptibility does not affect the selection/exclusion criteria for this trial. 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. Exclusion Criteria: 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.

Sites / Locations

  • Yonsei University Health System, Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bevacizumab + modified FOLFIRINOX

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Progression-free survival
Progression-free survival assessed using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) and Kaplan-Meier Survival analysis
Disease control rate
Disease control rate assessed using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) for Intention-to-treatment group
Overall survival
Overall survival assessed using Kaplan-Meier Survival analysis to check survival outcomes of Intention-to-treatment group
Number of Participants With Adverse Events (CTCAE v5.0)
Safety profiles assessed using Common Terminology Criteria for Adverse Events v5.0 (CTCAE v5.0)
Patient reported outcomes
Patient reported outcomes assessed using EQ-5D
Patient reported outcomes
Patient reported outcomes assessed using EORTC QLQ-CIPN20
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)

Full Information

First Posted
November 15, 2022
Last Updated
December 25, 2022
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT05665023
Brief Title
Bevacizumab Plus Modiifed FOLFIRINOX in Ovarian, Fallopian Tube, or Primary Peritoneal Mucinous Carcinoma
Official Title
Single-arm Phase II Study of Bevacizumab Plus Modified FOLFIRINOX Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Mucinous Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2022 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucinous Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
Keywords
mucinous ovarian cancer, fallopian tube cancer, primary peritoneal cancer, palliative, avastin, modified FOLFIRINOX

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bevacizumab + modified FOLFIRINOX
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Bevacizumab + modified FOLFIRINOX
Intervention Description
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 Measure Information:
Title
Objective response rate
Description
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
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
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
Title
Disease control rate
Description
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
Title
Overall survival
Description
Overall survival assessed using Kaplan-Meier Survival analysis to check survival outcomes of Intention-to-treatment group
Time Frame
up to 1 year
Title
Number of Participants With Adverse Events (CTCAE v5.0)
Description
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
Title
Patient reported outcomes
Description
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
Title
Patient reported outcomes
Description
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
Title
Febrile neutropenia prevention efficacy and safety profiles of Pegteograstim
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. *Platinum susceptibility does not affect the selection/exclusion criteria for this trial. 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Hwan Kim
Phone
+82-2-2228-8133
Email
gemgoon3691@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Hwan Kim
Organizational Affiliation
Division of Medical Oncology, Yonsei Cancer Center, Yonsei Univ. College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University Health System, Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Hwan Kim
Phone
+82-2-2228-8133
Email
gemgoon3691@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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