Pralatrexate in Combination With Oxaliplatin in Advanced Esophagogastric Cancer: A Phase II Trial With Predictive Molecular Correlates
PRIMARY OBJECTIVES: I. To determine the overall response rate in patients with advanced
esophago-gastric cancer 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 microRNA expression profiling of the epithelial component of the tumor.
OUTLINE: Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours
on day 1. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease
progression or unacceptable toxicity. After completion of study treatment, patients are
followed up for 30 days and then periodically thereafter for up to 5 years.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate to combination pralatrexate and oxaliplatin as assessed by RECIST
2 years
No
Nikhil Khushalani
Principal Investigator
Roswell Park Cancer Institute
United States: Institutional Review Board
I 169210
NCT01178944
September 2010
Name | Location |
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Roswell Park Cancer Institute | Buffalo, New York 14263 |