A Phase II Study of sFOLFOXIRI in Advanced Gastroesophageal Cancer (SAGE).
Hypothesis: We hypothesize that the use of sFOLFOXIRI in gastroesophageal cancer (GEC) will increase response rates beyond that expected with FOLFOX while maintaining acceptable tolerability.
Primary Objective:
- To determine the clinical efficacy of treatment regime in terms of objective response rate (ORR).
Secondary Objectives:
- To determine the clinical efficacy of the study treatment in terms of progression free survival (PFS) and overall survival (OS).
- To characterize the safety and toxicity profile of the study treatment as measured by the adverse event rates.
Stomach
FLUOROURACIL
5-Fluorouracil
Opdivo (Nivolumab)
- Rutgers Cancer Institute of New Jersey
- RWJBarnabas Health
- Community Medical Center
- Monmouth Medical Center
- Monmouth Medical Center Southern Campus
- Newark Beth Israel Medical Center
- Robert Wood Johnson University Hospital, Hamilton
- Rutgers Cancer Institute of New Jersey-University Hospital
Inclusion Criteria
- Histologically and/or cytologically confirmed metastatic or unresectable
adenocarcinoma of esophageal, gastroesophageal junction or gastric origin
- Tumor is HER2 negative by standard local testing methodology
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 - 2
- Measurable disease by response evaluation criteria in solid tumors (RECIST) v1.1
- No prior systemic therapy for the present cancer given in the metastatic setting and >
6 months from administration of peri-operative chemotherapy, if applicable
o Note: up to two prior cycles of mFOLFOX6 for the present illness is permitted if
patients otherwise qualify for the study with adequate baseline imaging
- At least 18 years of age
- Adequate bone marrow and organ functions as defined by:
- Absolute neutrophil count ≥ 1500 cells/ μL
- Hemoglobin ≥ 8 g/ dL
- Platelets > 100,000 / μL
- Creatinine ≤ 1.5 x upper limit of normal (ULN) OR creatinine clearance ≥ 30 mL/min by
Cockroft-Gault
- Total bilirubin ≤ ULN
- Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) < 2.5 x ULN, unless
with liver metastases and then must be <5 x ULN of normal
- Women and men of childbearing potential must agree to use adequate contraception
(hormonal or barrier method of birth control or abstinence) prior to study entry and
for the duration of study participation. Should a woman become pregnant or suspect
pregnancy on study, she must notify her treating physician immediately.
- Ability to understand the nature of this study protocol and give written informed
consent.
- Willingness and ability to comply with scheduled visits, treatment plans laboratory
tests and other study procedures.
Exclusion Criteria
- Receipt of any investigational agents at the time of registration
- Known, untreated brain metastases
- Grade two or greater peripheral neuropathy
- Presence of any additional active malignancy within the past three years where the
malignancy is at least reasonably likely to later the course of therapy, require
systemic therapy or interfere with imaging assessments
- For those patients who are going to receive nivolumab
- No active use of systemic corticosteroids at the time of enrollment, at a dose
equivalent of 10 mg/day or prednisone
- Clinically significant autoimmune disease which is active or has required systemic
immunosuppression within the last two years
- Prior organ transplant or bone marrow transplant
- History of interstitial lung disease or pneumonitis
- Uncontrolled intercurrent illness, including significant active infection, symptomatic
congestive heart failure, unstable angina or active arrhythmia
- Major surgery within the four weeks prior to initiation of study treatment
- A history of allergy or hypersensitivity to any of the study drugs
- Any additional significant medical condition, laboratory abnormality, or psychiatric
illness that would prevent the subject from fully participating in the study
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.