Fallopian Tube Cancer, Mucinous Ovarian Cancer, Primary Peritoneal Cancer
Conditions
Keywords
mucinous ovarian cancer, fallopian tube cancer, primary peritoneal cancer, palliative, avastin, modified FOLFIRINOX
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.
Interventions
DRUGBevacizumab + 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
Sponsors
Yonsei University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Overall survival | up to 1 year | Overall survival assessed using Kaplan-Meier Survival analysis to check survival outcomes of Intention-to-treatment group |
| 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 |
| 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 EQ-5D |
| 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) |
Countries
South Korea
Contacts
Primary ContactMin Hwan Kim
Outcome results
None listed