Status:
RECRUITING
sFOLFOXIRI in Advanced Gastroesophageal Cancer, (SAGE)
Lead Sponsor:
Rutgers, The State University of New Jersey
Conditions:
Gastro-Intestinal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective is to determine the clinical efficacy of treatment regimen in terms of objective response rate (ORR). The secondary objectives is to determine the clinical efficacy of the study ...
Detailed Description
The overall purpose of this protocol is to serve as a Single Arm Phase II trial of a four week alternating FOLFOX and FOLFIRI (sFOLFOXIRI), with or without nivolumab, in advanced human epidermal growt...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT05332002
Start Date
July 13 2022
End Date
August 1 2026
Last Update
January 7 2026
Active Locations (6)
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1
RWJBarnabas Health - Robert Wood Johnson University Hospital
Hamilton, New Jersey, United States, 08690
2
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, New Jersey, United States, 08701
3
RWJBarnabas Health - Monmouth Medical Center
Long Branch, New Jersey, United States, 07740
4
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903