Phase II Study of Pralatrexate and Docetaxel in Patients With Advanced Esophageal and Gastroesophageal Carcinoma Who Have Failed Prior Platinum-based Therapy.
PRIMARY OBJECTIVES:
I. To evaluate overall response rate (CR + PR as assessed by RECIST v 1.1) of the
combination of pralatrexate and docetaxel in patients with advanced esophageal and
gastroesophageal carcinomas.
SECONDARY OBJECTIVES:
I. Evaluation of progression free survival and overall survival. II. Correlation of FDG PET
response defined as a 35% reduction in SUV during the early course of chemotherapy to
progression free and overall survival in addition to radiographic response as measured by
RECIST v 1.1 criteria on CT imaging.
OUTLINE:
Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat
every 14 days in the absence of disease progression or unacceptable toxicity.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response
Approximately three years
No
Jeffrey Rose
Principal Investigator
Ohio State University
United States: Institutional Review Board
OSU-10018
NCT01129206
July 2010
Name | Location |
---|---|
Ohio State University | Columbus, Ohio 43210 |