Erlotinib and Radiation Therapy in Treating Older Patients With Stage I, Stage II, Stage III, or Stage IV Esophageal Cancer
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.
Drug: erlotinib hydrochloride
Other: immunohistochemistry staining method
Radiation: radiation therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Erlotinib (Tarceva®) and Radiotherapy for Elderly Patients With Esophageal Carcinoma|
- Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Complete Response [ Time Frame: 4-8 weeks after completion of radiation. ] [ Designated as safety issue: No ]
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 [ Time Frame: Every 3 months, up to 5 years ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and Week 3 ] [ Designated as safety issue: No ]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 [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Response by Epidermal Growth Factor Receptor (EGFR) Expression [ Time Frame: Radiologic evaluation every 3 months, up to 5 years ] [ Designated as safety issue: No ]
- Response by Phosphor Epidermal Growth Factor Receptor (pEGFR) Expression [ Time Frame: Radiologic evaluation every 3 months, up to 5 years ] [ Designated as safety issue: No ]
- Response by EGFR Mutation Status [ Time Frame: Radiologic evaluation every 3 months, up to 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2006|
|Study Completion Date:||October 2011|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Drug: erlotinib hydrochloride
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00524121
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Renuka Iyer, MD||Roswell Park Cancer Institute|