Mucinous Ovarian CancerPhase 2NCT05665023
Bevacizumab Plus Modiifed FOLFIRINOX in Ovarian, Fallopian Tube, or Primary Peritoneal Mucinous Carcinoma
A Phase 2 study testing Bevacizumab + modified FOLFIRINOX in people with Mucinous Ovarian Cancer and Fallopian Tube Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
This research study is evaluating a modified FOLFIRINOX plus bevacizumab therapy for mucinous ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Mucinous Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- What is being tested?
- Bevacizumab + modified FOLFIRINOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Oct 2022to 1 Feb 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul
Min Hwan Kim, +82-2-2228-8133, gemgoon3691@yuhs.ac
About this study
Official title: 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.
Read the 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.
- Being tested
- Bevacizumab + modified FOLFIRINOX
- Keywords
- mucinous ovarian cancer, fallopian tube cancer, primary peritoneal cancer, palliative, avastin, modified FOLFIRINOX
- Medical subject headings
- Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab + modified FOLFIRINOXDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Bevacizumab + modified FOLFIRINOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Objective response rate assessed using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) for Intention-to-treatment group
Measured: up to 1 year
Secondary outcomes (7)
Progression-free survival
Progression-free survival assessed using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) and Kaplan-Meier Survival analysis
Measured: 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
Measured: at 6 months
Overall survival
Overall survival assessed using Kaplan-Meier Survival analysis to check survival outcomes of Intention-to-treatment group
Measured: 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)
Measured: from the start to within 30 days of the final chemotherapy
Patient reported outcomes
Patient reported outcomes assessed using EQ-5D
Measured: 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
Measured: 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)
Measured: from the start to within 30 days of the final chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start28 Oct 2022
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucinous Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Hwan Kim, Principal investigator, Division of Medical Oncology, Yonsei Cancer Center, Yonsei Univ. College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665023
- Sponsor's protocol ID
- 4-2021-1776
- Status last verified
- Dec 2022
- First submitted
- 15 Nov 2022
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm Phase II Study of Bevacizumab Plus Modified FOLFIRINOX Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Mucinous Carcinoma
- ClinicalTrials.gov ID
- NCT05665023
- Acronym / sponsor ID
- 4-2021-1776
- Keywords
- mucinous ovarian cancer, fallopian tube cancer, primary peritoneal cancer, palliative, avastin, modified FOLFIRINOX
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab + modified FOLFIRINOX | Experimental | Drug: Bevacizumab + modified FOLFIRINOXBevacizumab 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bevacizumab + modified FOLFIRINOXBevacizumab 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 |
Primary outcome
Objective response rate
Time frame: 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
7 secondary outcomes
Progression-free survival
Time frame: up to 1 year
Disease control rate
Time frame: at 6 months
Overall survival
Time frame: up to 1 year
Number of Participants With Adverse Events (CTCAE v5.0)
Time frame: from the start to within 30 days of the final chemotherapy
Patient reported outcomes
Time frame: at the beginning and every 4 cycles of the treatment (each cycle is 14 days), up to 1 year
Patient reported outcomes
Time frame: 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
Time frame: from the start to within 30 days of the final chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Individual participant dataSharing planned: No
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Ovarian Brenner Tumor, Ovarian Clear Cell Cystadenocarcinoma
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Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine With or Without Bevacizumab as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II-IV or Recurrent Stage I Epithelial Ovarian or Fallopian Tube Cancer
Borderline Ovarian Mucinous Tumor, Ovarian Mucinous Cystadenocarcinoma
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TORC1/2 Inhibitor MLN0128 and Bevacizumab in Treating Patients With Recurrent Glioblastoma or Advanced Solid Tumors
Adult Glioblastoma, Endometrial Clear Cell Adenocarcinoma
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MV-NIS Infected Mesenchymal Stem Cells in Treating Recurrent Ovarian, Primary Peritoneal or Fallopian Tube Cancer
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Hwan Kim principal investigator
Division of Medical Oncology, Yonsei Cancer Center, Yonsei Univ. College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab + modified FOLFIRINOX in people with Mucinous Ovarian Cancer and Fallopian Tube Cancer, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Hwan Kim (+82-2-2228-8133, gemgoon3691@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.