Esophageal Cancer Clinical Trials

Find Esophageal Cancer Clinical Trials Near You

A Phase II Study of sFOLFOXIRI in Advanced Gastroesophageal Cancer (SAGE)

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
New Jersey
RWJBarnabas Health - Robert Wood Johnson University Hospital
RECRUITING
Hamilton
RWJBarnabas Health - Monmouth Medical Center Southern Campus
RECRUITING
Lakewood
RWJBarnabas Health - Monmouth Medical Center
RECRUITING
Long Branch
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset
RECRUITING
New Brunswick
RWJBarnabas Health - Newark Beth Israel Medical Center
RECRUITING
Newark
Contact Information
Primary
Patrick Boland, MD
pb564@cinj.rutgers.edu
(732)235-2465
Time Frame
Start Date: 2022-07-13
Estimated Completion Date: 2026-08-01
Participants
Target number of participants: 38
Treatments
Other: 4week alternating FOLFOX and a combination chemotherapy regime FOLFIRI (sFOLFOXIRI),
A cycle will constitute 28 days of treatment, which will consist of one chemotherapy combination, either FOLFOX or FOLFIRI as below:~1. Odd Cycles (e.g. 1, 3, 5, etc…) - mFOLFOX6 initiated on days 1 \& 15: (Oxaliplatin 85 mg/m2 IV, leucovorin 400 mg/m2, 5FU 400 mg/m2 bolus, then 5FU 2400 mg/m2 over 46 hours)~2. Even Cycles (e.g. 2,4,6, etc…) - FOLFIRI initiated on days 1 \& 15: (Irinotecan 180 mg/m2 IV, leucovorin 400 mg/m2, 5FU 400 mg/m2 bolus, then 5FU 2400 mg/m2 over 46 hours)~3. Nivolumab (optional, in-line with labelled approval) - 240 mg every 2 weeks
Related Therapeutic Areas
Sponsors
Leads: Rutgers, The State University of New Jersey

This content was sourced from clinicaltrials.gov