NCT01129206

Pralatrexate and Docetaxel in Treating Patients With Stage IV Esophageal or Gastroesophageal Cancer Who Have Failed Platinum-Based Therapy

Phase II Study of Pralatrexate and Docetaxel in Patients With Advanced Esophageal and Gastroesophageal Carcinoma Who Have Failed Prior Platinum-based Therapy.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adenocarcinoma of the Esophagus
• Adenocarcinomas of the Gastroesophageal Junction
• Recurrent Esophageal Cancer
• Squamous Cell Carcinoma of the Esophagus
• Stage IV Esophageal Cancer

Interventions

Type	Name	Description
DRUG	pralatrexate	IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.
DRUG	docetaxel	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.
RADIATION	fludeoxyglucose F 18	Correlative studies
PROCEDURE	positron emission tomography	Correlative studies

Timeline

• Start date: 2010-07-01
• Primary completion: 2012-09-01
• First posted: 2010-05-24
• Last updated: 2016-06-01
• Results posted: 2015-10-16

Locations

1 site across 1 country: United States