Adenocarcinoma of the Gastroesophageal Junction Clinical Trial
Official title:
Phase Ib Trial of mFOLFOX6 and Everolimus (NSC-733504) in Patients With Metastatic Gastroesophageal Adenocarcinoma
RATIONALE: Everolimus may stop the growth of stomach or esophageal cancer by blocking blood
flow to the tumor. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and
oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the
cells or by stopping them from dividing, or by stopping them from spreading. Giving
everolimus together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when
given together with combination chemotherapy in treating patients with metastatic stomach or
esophageal cancer that has spread to other places in the body.
OBJECTIVES:
I. To determine the maximum tolerated dose of everolimus to use in combination with mFOLFOX6
[oxaliplatin, leucovorin (leucovorin calcium), 5-FU (fluorouracil)].
II. To better describe the toxicities associated with the combination of everolimus with
mFOLFOX6.
III. To assess response rate and progression-free survival in this patient population.
IV. To assess overall survival in patients with metastatic gastric, esophageal and
gastroesophageal junction (GEJ) adenocarcinoma treated with the combination of mFOLFOX6 +
everolimus.
OUTLINE: This is a dose-escalation study of everolimus. Patients receive fluorouracil
intravenously (IV) continuously over 46 hours, leucovorin calcium IV over 2 hours, and
oxaliplatin IV over 2 hours on day 1. Patients also receive oral everolimus once daily on
days 1-28. Courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up periodically for 1 year.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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