PhIII TrialmFOLFIRINOX+/-NivolumabVSFOLFOX+/-NivolumabFirstTime Tx MetaHER2-Neg GastroesophAdenocarc

UCI Specialty Area: Cancer

Principal Investigator: Farshid Dayyani

Official Title: A Randomized Phase III Trial of mFOLFIRINOX +/- Nivolumab vs. FOLFOX +/- Nivolumab for First-line Treatment of Metastatic HER2-negative Gastroesophageal Adenocarcinoma

A Study On:

Esophagus

Stomach

Study Description

This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) for the treatment of advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, and gastric adenocarcinoma. The usual approach for patients is treatment with FOLFOX chemotherapy. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Fluorouracil stops cells from making DNA and it may kill tumor cells. Leucovorin is used with fluorouracil to enhance the effects of the drug. Oxaliplatin works by killing, stopping, or slowing the growth of tumor cells. Some patients also receive an immunotherapy drug, nivolumab, in addition to FOLFOX chemotherapy. Immunotherapy may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Irinotecan blocks certain enzymes needed for cell division and DNA repair, and it may kill tumor cells. Adding irinotecan to the FOLFOX regimen could shrink the cancer and extend the life of patients with advanced gastroesophageal cancers.

Eligibility

Negative adenocarcinoma as defined by American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP)
No prior treatment for unresectable or metastatic disease
Prior neoadjuvant or adjuvant cytotoxic chemotherapy or adjuvant immunotherapy is allowed as long as it was completed at least 1 year prior to registration
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Patients positive for human immunodeficiency virus (HIV) are eligible only if they meet all of the following:
On effective anti-retroviral therapy
Undetectable HIV viral load by standard clinical assay equal/less than 6 months of registration
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function
Patients who will receive nivolumab in addition to chemotherapy must not have any contraindications to immune checkpoint inhibitors
Ability to complete study questionnaire available in English, Spanish, Korean, Chinese (Simplified), and Russian

Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects
No known Gilbert's syndrome or known homozygosity for UGAT1A1*28 polymorphism
No baseline grade greater than/ equal to 2 peripheral neuropathy, neurosensory toxicity, or neuromotor toxicity
No medical condition such as uncontrolled infection or uncontrolled diabetes mellitus
No untreated, symptomatic brain metastasis
No allogeneic tissue/organ transplant

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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Future Research Use
Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information

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