Oxaliplatin, Fluorouracil, Erlotinib Hydrochloride, and Radiation Therapy Before Surgery and Erlotinib Hydrochloride After Surgery in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction

Summary

This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given together with oxaliplatin, fluorouracil, and radiation before surgery and alone after surgery in treating patients with locally advanced cancer of the esophagus and gastroesophageal junction. Drugs used in chemotherapy, such as oxaliplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with erlotinib hydrochloride and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving erlotinib hydrochloride after surgery may kill any tumor cells that remain after surgery

Conditions

• Adenocarcinoma of the Esophagus
• Adenocarcinoma of the Gastroesophageal Junction
• Adenocarcinoma of the Stomach
• Squamous Cell Carcinoma of the Esophagus
• Stage II Esophageal Cancer
• Stage II Gastric Cancer
• Stage III Esophageal Cancer
• Stage III Gastric Cancer

Interventions

DRUG

erlotinib hydrochloride

Given PO

DRUG

oxaliplatin

Given IV

DRUG

fluorouracil

Given IV

RADIATION

radiation therapy

Undergo radiotherapy

PROCEDURE

conventional surgery

Undergo surgical resection

OTHER

immunohistochemistry staining method

Correlative study

PROCEDURE

positron emission tomography

Correlative study

PROCEDURE

computed tomography

Correlative study

PROCEDURE

laboratory biomarker analysis

Correlative study

GENETIC

gene expression analysis

Correlative study

RADIATION

fludeoxyglucose F 18

Undergo F18 PET and CT scan

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Wake Forest University Health Sciences

  lead OTHER

Principal Investigators

• Arthur Blackstock · Wake Forest University Health Sciences

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-04-30

Primary Completion

2009-03-31

Completion

2009-03-31

FDA Drug

Yes

Countries

• United States

Study Locations