Esophageal Cancer Clinical Trial

sFOLFOXIRI in Advanced Gastroesophageal Cancer, (SAGE)

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 treatment in terms of progression free survival (PFS) and overall survival (OS). Additionally, to characterize the safety and toxicity profile of the study treatment as measured by the adverse event rates.

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Full 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 growth factor receptor two (HER2) negative gastric and esophageal cancers (GEC). This study evaluates the hypothesis that the use of sFOLFOXIRI in gastroesophageal cancer (GEC) will increase response rates beyond that expected with FOLFOX, while maintaining acceptable tolerability. The primary endpoint of this study is the objective response rate (ORR) while the key secondary endpoints include the progression free survival (PFS), overall survival (OS), and adverse event (AE) rates. The goal of this study is to establish the activity level of sFOLFOXIRI, with the thought that this could be further developed in the metastatic and/or peri-operative space if a sufficiently interesting degree of efficacy is observed.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

38

Study ID:

NCT05332002

Recruitment Status:

Recruiting

Sponsor:

Rutgers, The State University of New Jersey

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There are 6 Locations for this study

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RWJBarnabas Health - Robert Wood Johnson University Hospital
Hamilton New Jersey, 08690, United States More Info
Patrick Boland, MD
Contact
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood New Jersey, 08701, United States More Info
Patrick Boland, MD
Contact
RWJBarnabas Health - Monmouth Medical Center
Long Branch New Jersey, 07740, United States More Info
Patrick Boland, MD
Contact
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08903, United States More Info
Patrick Boland, MD
Contact
RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset
New Brunswick New Jersey, 08903, United States More Info
Patrick Boland, MD
Contact
RWJBarnabas Health - Newark Beth Israel Medical Center
Newark New Jersey, 07112, United States More Info
Patrick Boland, MD
Contact
RWJBarnabas Health - Community Medical Center
Toms River New Jersey, 08755, United States More Info
Patrick Boland, MD
Contact

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

38

Study ID:

NCT05332002

Recruitment Status:

Recruiting

Sponsor:


Rutgers, The State University of New Jersey

How clear is this clinincal trial information?

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