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Pralatrexate and Oxaliplatin in Treating Patients With Unresectable or Metastatic Esophageal, Stomach, or Gastroesophageal Junction Cancer

NCT01178944 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2017-12-13

Study results available
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Summary

This phase II trial studies how well pralatrexate and oxaliplatin work in treating patients with esophageal, stomach, or gastroesophageal junction cancer that cannot be removed by surgery or has spread from the primary site (place where it started) to other places in the body. Pralatrexate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pralatrexate with oxaliplatin may be an effective treatment for esophageal, stomach, or gastroesophageal junction cancer.

Conditions

  • Adenocarcinoma of the Gastroesophageal Junction
  • Esophageal Undifferentiated Carcinoma
  • Gastric Adenocarcinoma
  • Gastric Squamous Cell Carcinoma
  • Recurrent Esophageal Adenocarcinoma
  • Recurrent Esophageal Squamous Cell Carcinoma
  • Recurrent Gastric Carcinoma
  • Stage IIIB Esophageal Adenocarcinoma
  • Stage IIIB Esophageal Squamous Cell Carcinoma
  • Stage IIIB Gastric Cancer
  • Stage IIIC Esophageal Adenocarcinoma
  • Stage IIIC Esophageal Squamous Cell Carcinoma
  • Stage IIIC Gastric Cancer
  • Stage IV Esophageal Adenocarcinoma
  • Stage IV Esophageal Squamous Cell Carcinoma
  • Stage IV Gastric Cancer
  • Undifferentiated Gastric Carcinoma

Interventions

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Oxaliplatin

Given IV

DRUG

Pralatrexate

Given IV

Sponsors & Collaborators

Principal Investigators

  • Nikhil Khushalani · Roswell Park Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2015-01-31
Completion
2015-11-30

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 NCT01178944 on ClinicalTrials.gov