Stage IV Esophageal Cancer Clinical Trial
Official title:
Phase II Study of Pralatrexate and Docetaxel in Patients With Advanced Esophageal and Gastroesophageal Carcinoma Who Have Failed Prior Platinum-based Therapy.
RATIONALE: Pralatrexate may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving pralatrexate together with docetaxel may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving pralatrexate together with
docetaxel works in treating patients with stage IV esophageal or gastroesophageal cancer who
have failed platinum-based therapy.
PRIMARY OBJECTIVES:
I. To evaluate overall response rate CR & PR(Complete Response + Partial Response)as
assessed by RECIST (Response Evaluation Criteria in Solid Tumors 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(fludeoxyglucose)PET(positron emission tomography)response defined as a 35% reduction in
SUV(standard uptake value)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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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