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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Roswell Park Cancer Institute
Buffalo, New York, United States
Overall Survival
Time frame: 5 years
Complete Response
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.
Time frame: 4-8 weeks after completion of radiation.
Progresssion-Free Survival
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.
Time frame: Every 3 months, up to 5 years
Effect of Study Therapy on Overall Quality of Life as Assessed by FACT-E Scale
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
Time frame: Baseline and Week 3
Correlation of Smoking Status With Overall Survival
Time frame: 5 years
Response by Epidermal Growth Factor Receptor (EGFR) Expression
Time frame: Radiologic evaluation every 3 months, up to 5 years
Response by Phosphor Epidermal Growth Factor Receptor (pEGFR) Expression
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Time frame: Radiologic evaluation every 3 months, up to 5 years
Response by EGFR Mutation Status
Time frame: Radiologic evaluation every 3 months, up to 5 years