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

NCT01129206 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2016-06-01

Study results available
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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.

Conditions

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Tony Saab, MD · Ohio State University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2012-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01129206 on ClinicalTrials.gov