Health TrialsbyHealthPanel

sFOLFOXIRI in Advanced Gastroesophageal Cancer, (SAGE)

ConditionGastro-Intestinal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRutgers, The State University of New Jersey

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Four week alternating FOLFOX and FOLFIRI (sFOLFOXIRI)

    Drug

    This is a Single Arm Phase II trial of q4week alternating FOLFOX and FOLFIRI (sFOLFOXIRI), with or without nivolumab, in advanced human epidermal growth factor receptor 2 (HER2) negative gastric and esophageal cancers (GEC). The study treatment is a chemotherapy combination of either FOLFOX or FOLFIRI as below: 1. mFOLFOX6: (Oxaliplatin 85 mg/m2 IV, leucovorin 400 mg/m2, 5-FU 400 mg/m2 bolus, then 5-FU 2400 mg/m2: 2. FOLFIRI: (Irinotecan 180 mg/m2 IV, leucovorin 400 mg/m2, 5-FU 400 mg/m2 bolus, then 5-FU 2400 mg/m2 3. Nivolumab(Optional) The chemotherapy combination of FOLFOX and FOLFIRI is a FDA approved treatment for advanced bowel and gastric

Treatment groups

38 Participants
are divided into 1 treatment group
Group A: 4week alternating FOLFOX and a combination chemotherapy regime FOLFIRI (sFOLFOXIRI),Other 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors ( RECIST) criteria version 1.1

To determine the clinical efficacy of treatment regimen in terms of objective response rate.

Time frame
Three Years
2

Progression Free Survival (PFS)

To determine the clinical efficacy of the study treatment in terms of progressive free survival.

Time frame
Three Years
3

Overall Survival (OS)

To determine the clinical efficacy of the study treatment in terms of overall survival.

Time frame
Three Years
4

Adverse Event Rates

Time frame
Three Years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rutgers, The State University of New Jersey

Lead sponsor

Source ClinicalTrials.gov
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