Erlotinib and Radiation Therapy in Treating Older Patients With Stage I, Stage II, Stage III, or Stage IV Esophageal Cancer

Phase 2

Completed

Conditions: Esophageal Cancer

Interventions: Drug: erlotinib hydrochloride
Other: immunohistochemistry staining method
Radiation: radiation therapy

Registration Number: NCT00524121

Lead Sponsor: Roswell Park Cancer Institute

Brief Summary: RATIONALE: Erlotinib 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 erlotinib together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving erlotinib together with radiation therapy works in treating older patients with stage I, stage II, stage III, or stage IV esophageal cancer.

Detailed Description: OBJECTIVES:

Primary

* Assess the overall survival of older patients with stage I-IV squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction treated with erlotinib hydrochloride in combination with radiotherapy.

Secondary

* Assess the proportion of patients achieving mucosal complete response after treatment with this regimen.

* Determine the progression-free survival of patients treated with this regimen.

* Assess the effect of this regimen on dysphagia control, performance status, and overall quality of life of these patients.

* Investigate the correlation between smoking status and overall survival of these patients.

* To correlate the Epidermal growth factor receptor (EGFR) and phosphor Epidermal growth factor receptor (pEGFR) expression by IHC and EGFR mutation status with clinical outcomes.

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib hydrochloride once daily for 1 year in the absence of disease progression or unacceptable toxicity. Patients undergo external beam radiotherapy 5 days a week in weeks 1-4 or 5 days a week for the first 5.5 weeks.

Tumor tissue samples are analyzed by IHC for the expression of E-cadherin, P-cadherin, vimentin, cytokeratin, phospho-S6, and Ki67.

After completion of study treatment, patients are followed at 30 days and annually thereafter.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oral Erlotinib	immunohistochemistry staining method	Patients receive oral erlotinib hydrochloride once daily for 1 year
Oral Erlotinib	erlotinib hydrochloride	Patients receive oral erlotinib hydrochloride once daily for 1 year
Oral Erlotinib	radiation therapy	Patients receive oral erlotinib hydrochloride once daily for 1 year

Primary Outcome Measures

Name	Time	Method
Overall Survival	5 years

Secondary Outcome Measures

Name	Time	Method
Complete Response	4-8 weeks after completion of radiation.	Response assessment by CT scans and upper endoscopy performed between 4-8 weeks after completion of radiation. Complete Response (CR) is defined as absence of viable tumor in endoscopic evaluation post chemoradiation, with four-quadrant biopsies taken at 1 cm intervals throughout length of original tumor.
Progresssion-Free Survival	Every 3 months, up to 5 years	Progression is defined as at least a 20% increase in the sum of long distance of target lesions taking as reference the smallest sum long distance recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Effect of Study Therapy on Overall Quality of Life as Assessed by FACT-E Scale	Baseline and Week 3	Functional Assessment of Cancer Therapy-Esophagus (FACT-E) is a health-related quality of life instrument validated in esophageal cancer patients. All of the scales and single-item measures range in score from 0 to 4. The ranges of average quality of life scores was from 0 to 4 and was adjusted as lower scores indicate better outcomes
Correlation of Smoking Status With Overall Survival	5 years
Response by Epidermal Growth Factor Receptor (EGFR) Expression	Radiologic evaluation every 3 months, up to 5 years
Response by Phosphor Epidermal Growth Factor Receptor (pEGFR) Expression	Radiologic evaluation every 3 months, up to 5 years
Response by EGFR Mutation Status	Radiologic evaluation every 3 months, up to 5 years