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

Last updated: December 25, 2022
Sponsor: Yonsei University
Overall Status: Active - Recruiting

Phase

2

Condition

Ovarian Cysts

Fallopian Tube Cancer

Pelvic Cancer

Treatment

N/A

Clinical Study ID

NCT05665023
4-2021-1776
  • Ages > 19
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with recurrent, metastatic, or unresectable ovarian cancer, fallopian tubecancer, or primary peritoneal cancer diagnosed cytologically or histologically asmucinous cancer. *Subjects who are metastatic (stage IV) or mucinous ovarian cancer that cannot besurgically resected at diagnosis may have undergone cytoreductive surgery prior tosystemic chemotherapy. It is appropriate for participation in this study if there areresidual lesions after surgery and other selection criteria are met.
  2. Mucous tumors of gastrointestinal origin should be excluded by prior upper and lowerintestinal 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, orwho have failed second-line or less systemic chemotherapy. However, immunotherapyalone (eg, anti-PD-1 or anti-PD-L1 immunotherapy) is not included in previouschemotherapy. *Platinum susceptibility does not affect the selection/exclusion criteria for thistrial.
  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 urineor serological test or consent to the use of an appropriate contraceptive method.

Exclusion

Exclusion Criteria:

  1. Patients who have previously received systemic chemotherapy, including oxaliplatin oririnotecan. *Previous treatment with bevacizumab is acceptable.
  2. Pregnant or breastfeeding women
  3. Patients who received chemotherapy, targeted small-molecule agents, or radiotherapywithin 2 weeks prior to Day 1 of the study, or who have not yet recovered (Grade 1 orlower 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 tumorsrequiring aggressive treatment.
  6. Patients with moderate acute or chronic medical conditions or abnormal findings onexamination, which are judged to affect the results of this study
  7. Infected with Human Immunodeficiency Virus (HIV) (HIV-1/2 antibody) infection oractive 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 Design

Total Participants: 37
Study Start date:
October 28, 2022
Estimated Completion Date:
February 01, 2025

Study 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.

Connect with a study center

  • Yonsei University Health System, Severance Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

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