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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• erlotinib hydrochloride — DRUG
  Given PO
• oxaliplatin — DRUG
  Given IV
• fluorouracil — DRUG
  Given IV
• radiation therapy — RADIATION
  Undergo radiotherapy
• conventional surgery — PROCEDURE
  Undergo surgical resection
• immunohistochemistry staining method — OTHER
  Correlative study
• positron emission tomography — PROCEDURE
  Correlative study
• computed tomography — PROCEDURE
  Correlative study
• laboratory biomarker analysis — PROCEDURE
  Correlative study
• gene expression analysis — GENETIC
  Correlative study
• fludeoxyglucose F 18 — RADIATION
  Undergo F18 PET and CT scan

Study Details

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

Key Dates

First listed

Mar 22, 2012

Start date

Apr 30, 2007

Status verified

Jun 2018

Primary completion

Mar 31, 2009

Completion

Mar 31, 2009

Study Design

Enrollment

9 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (chemotherapy, enzyme inhibitor therapy)
  CHEMORADIOTHERAPY: Patients undergo radiation therapy QD, 5 days a week and receive fluorouracil IV continuously and erlotinib hydrochloride PO QD on days 1-38. Patients also receive oxaliplatin IV over 2 hours on days 1, 15, and 29. SURGERY: Within 4-8 weeks after completion of chemoradiotherapy, patients with potentially resectable disease (i.e., complete response, partial response, or stable disease) undergo surgery to remove the tumor. CONSOLIDATION CHEMOTHERAPY: Within 2-4 weeks after surgery, patients with tumors that demonstrate positive immunohistochemistry for EGFR and/or cyclin D1 (in the pretreatment biopsy or in the residual tumor in the esophagectomy specimen) receive consolidation chemotherapy comprising erlotinib hydrochloride PO QD for 12 weeks.

Primary Outcome Measure

Toxicity rate of combination chemotherapy followed by surgery and erlotinib hydrochloride [ Time Frame: Approximately 6 months ]

Locations (1)

Find similar trials in Winston-Salem, NC

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