Gastric Adenocarcinoma Clinical Trial
Official title:
Pralatrexate in Combination With Oxaliplatin in Advanced Esophago-gastric Cancer: A Phase II Trial With Predictive Molecular Correlates
This phase II trial studies how well pralatrexate and oxaliplatin work in treating patients with esophageal, stomach, or gastroesophageal junction cancer that cannot be removed by surgery or has spread from the primary site (place where it started) to other places in the body. Pralatrexate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, 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. Giving pralatrexate with oxaliplatin may be an effective treatment for esophageal, stomach, or gastroesophageal junction cancer.
PRIMARY OBJECTIVES:
I. To determine the overall response rate in patients with advanced esophago-gastric cancer
(EGC) to combination pralatrexate and oxaliplatin.
SECONDARY OBJECTIVES:
I. To examine the toxicity and tolerability of this regimen. II. To determine the
time-to-progression and overall survival using this regimen.
III. To examine whether functionally relevant polymorphisms of genes of the folate metabolism
pathway correlate with efficacy and toxicity of pralatrexate.
IV. To examine whether response to pralatrexate can be predicted by micro-ribonucleic acid
(microRNA) expression profiling of the epithelial component of the tumor.
OUTLINE:
Patients receive pralatrexate intravenously (IV) over 3-5 minutes and oxaliplatin IV over 2
hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or
unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses.
After completion of study treatment, patients are followed up for 30 days and then
periodically thereafter for up to 5 years.
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