Single-arm phase II study of bevacizumab plus modified FOLFIRINOX chemotherapy in ovarian, fallopian tube, or primary peritoneal mucinous carcinoma
- Conditions
- Neoplasms
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 37
1) Patients must have recurrent, metastatic, or inoperable ovarian cancer, fallopian tube cancer, or primary peritoneal carinoma with cytologic/pathologic diagnosis of mucinous carcinoma
2) Mucinous carcinoma originating from ovary, fallopian tube, or peritoneum. Mucinous carcinoma of gastrointestinal origin must be previously ruled out via upper and lower gastrointestinal endoscopy and by pathologic immunohistochemical staining (CEA, SATB2, etc).
3) Patients without previous systemic chemotherapy or progressed after treatment with 1 to 2 lines of prior standard of care chemotherapy are eligible.
NOTE) Immunotherapy(anti-PD-1 or anti-PD-L1) do not contribute to count of prior lines of chemotherapy.
4) Patients must have ability to understand and the willingness to sign a written informed consent document
5) Patients must be at least 19 years or older at the time of signing the informed consent form.
6) At least 1 measurable lesion that qualifies as a RECIST 1.1 Target Lesion at baseline and can be accurately measured at baseline.
7) ECOG PS of 0 or 1
8) Adequate organ and bone marrow functions defined as follows :
A. Absolute neutrophil count(ANC) = 1500 cells / mm3
B. Platelet count = 100,000/mm3
C. Hemoglobin = 9.0 g/dL. Red blood cell/plasma transfusion is not permitted within 1 week
prior to screening assessment.
D. Total bilirubin: = 2.0 × ULN
E. AST(SGOT) = 3.0 × ULN ; however, if elevation is due to liver metastases, = 5.0 × ULN is allowed.
F. ALT(SGPT) = 3.0 × ULN ; however, if elevation is due to liver metastases, = 5.0 × ULN is allowed.
G. Calculated creatinine clearance: = 30 mL/min as calculated using the CockcroftGault equation or serum creatinine = 1.5 × ULN
9) Reproduction
-Negative pregnancy test (urine and/or serum) for women of childbearing potential within 72 hours before Cycle 1 Day 1.
-Female participants must be post-menopausal for at least 1 year, surgically sterile, or agree to using two highly method of birth control. For women of childbearing potential who intend to be sexually active must agree to use two highly effective method of birth control throughout the total duration of the study and 180 days after the last dose.
1) Patients who have received prior systemic anti-cancer therapy, including oxaliplatin or irinotecan, for the treatment of mucinous ovarian/tubal/primary peritoneal cancer. Prior bevacizumab therapy is allowed.
2) Patients with moderate acute or chronic medical conditions or abnormal laboratory findings that may affect the outcome of this study.
3) Pregnant women or women who are breastfeeding.
4) Patients who have received chemotherapy, targeted small molecule agents, or radiotherapy within 2 weeks prior to Day 1 of this study or who have not yet recovered (to Grade 1 or less or to baseline) from adverse events due to previously administered agents.
5) Patients with other known malignancies that are worsening or requiring active treatment within the last 3 years. Exceptions are basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and thyroid or cervical squamous cell carcinoma that have received curative treatment.
6) Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients previously treated for brain metastases may participate in this study if they are clinically stable (no evidence of disease progression on imaging studies and return of all neurologic symptoms to baseline levels for at least 4 weeks prior to the first dose of study drug), have no evidence of new or progressive brain metastases, and have not used steroids for at least 7 days prior to study drug administration. This exclusion does not apply to carcinomatous meningitis, regardless of whether the clinical condition is stable or not.
7) Patients with a history or current evidence of any disease, treatment, or laboratory abnormality that, in the opinion of the investigator, would confound the results of the study, interfere with the patient's participation in the full duration of the study, or whose participation in the study would not be in the patient's best interest.
8) Cardiac dysfunction or clinically significant cardiac disease, including the following
- Clinically significant or uncontrolled cardiac disease (e.g., congestive heart failure requiring treatment [NYHA class 2 or greater], uncontrolled hypertension, or clinically significant arrhythmia).
- QTcF > 470 msec or congenital QT prolongation syndrome by screening ECG
- Acute myocardial infarction or unstable angina within 3 months prior to study enrollment
9) Patients with known psychiatric illness or substance abuse disorder that would interfere with compliance with study requirements.
10) Patients who are pregnant or lactating, or plan to become pregnant during the scheduled study period from the screening visit through Day 180 after the last dose of study drug.
11) Patients with a known history of human immunodeficiency virus (HIV) (HIV-1/2 antibodies).
12) Patients with known hepatitis B (however, patients with a positive HBsAg response and undetectable HBV DNA load are allowed) or hepatitis C (positive Anti-HCV antibody and [qualitatively] detectable HCV RNA).
13) Patients who have received a live vaccine within 30 days prior to the scheduled first dose of this study drug.
14) Active systemic infections that are not resolving.
15) Patients with known hypersensitivity or history of serious adverse reactions to 5-FU, leucovorin, oxaliplatin, or irinotecan.
16) Patients with peripheral sensory neuropathy greater than or equal to grade 3 according to CTCAE 5.0.
17) Patients with any of the following contraindications
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate (ORR)
- Secondary Outcome Measures
Name Time Method Profression-free survival(PFS);Disease control rate(DCR);Overall survival (OS);Drug safety evaluated by CTCAE 5.0;Quality of Life, assessed by patient-reported outcome(PRO) EQ-5D, EORTC-QLQ-CIPN20 questionnaire;Efficacy and safety evaluation for pegteofilgrastim;Exploratory biomarker analysis