Conditions: Adenocarcinoma of the Esophagus Adenocarcinomas of the Gastroesophageal Junction Recurrent Esophageal Cancer Squamous Cell Carcinoma of the Esophagus Stage IV Esophageal Cancer
Keywords: Gastroesophageal Cancer Gastroesophageal Carcinoma Adenocarcinoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 6
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: 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.

Interventions: intervention 1: pralatrexate intervention 2: docetaxel intervention 3: fludeoxyglucose F 18 intervention 4: positron emission tomography
Intervention descriptions: intervention 1: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2. intervention 2: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days. intervention 3: Correlative studies intervention 4: Correlative studies

Protocol document: