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

This study has been completed.
Information provided by (Responsible Party):
Roswell Park Cancer Institute Identifier:
First received: August 31, 2007
Last updated: March 14, 2016
Last verified: March 2016

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.

Condition Intervention Phase
Esophageal Cancer
Drug: erlotinib hydrochloride
Other: immunohistochemistry staining method
Radiation: radiation therapy
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Complete Response [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ 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 [ 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 ]

Enrollment: 22
Study Start Date: March 2006
Study Completion Date: October 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral Erlotinib
Patients receive oral erlotinib hydrochloride once daily for 1 year
Drug: erlotinib hydrochloride
Other: immunohistochemistry staining method
Correlative Study
Radiation: radiation therapy
Radiation Treatment

Detailed Description:



  • 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.


Ages Eligible for Study:   65 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Biopsy-proven primary squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal (GE) junction

    • GE junction tumors with 50% or more tumor located in the esophagus determined by radiologic or endoscopic evaluation
    • Stage I-IVA disease determined by CT scan or MRI of the chest and abdomen

      • Stage IVB disease allowed if metastases to distant regional lymph nodes (celiac or cervical) only and no other sites
  • Not a surgical candidate and ineligible for chemotherapy due to any of the following:

    • Neuropathy
    • Cardiac disease
    • Performance status 2
    • General overall condition felt by the investigator to be a contraindication to platinum-based therapy
  • Bronchoscopy with biopsy and cytology required if primary esophageal cancer is < 26 cm from incisors
  • No evidence of clinically active interstitial lung disease (patients who are asymptomatic with chronic, stable, radiographic lung changes allowed)


  • ECOG performance status 0-2
  • Life expectancy > 4 months
  • WBC ≥ 3,000/mm³
  • ANC ≥ 1,500/mm³
  • Platelet count > 100,000/mm³
  • Bilirubin ≤ 1.3 mg/dL
  • ALT and AST ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • No prior malignancies except basal cell or squamous cell skin cancer, in situ cervical cancer, or superficial transitional cell bladder cancer, unless diagnosed and/or treated > 2 years prior to current study and are without evidence of recurrence
  • No history of allergy to erlotinib or any of its excipients
  • No serious, uncontrolled, concurrent infection
  • No clinically serious, uncontrolled medical conditions that the investigator feels might compromise study participation
  • No lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
  • No unwillingness to participate or inability to comply with the protocol for the duration of the study


  • No prior chemotherapy or radiotherapy for this tumor
  • No prior resection or attempted resection of esophageal cancer
  • No prior anti-epidermal growth factor receptor therapy (unless given in an adjuvant setting and completed at least 12 months earlier)
  • No participation in any investigational drug study within the past 4 weeks
  • No HIV-positive patients receiving antiretroviral therapy
  • No concurrent CYP3A4/5 inducers or inhibitors
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Please refer to this study by its identifier: NCT00524121

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Principal Investigator: Renuka Iyer, MD Roswell Park Cancer Institute
  More Information

Responsible Party: Roswell Park Cancer Institute Identifier: NCT00524121     History of Changes
Other Study ID Numbers: CDR0000563268
RPCI-I-62705 ( Other Identifier: Roswell Park Cancer Institute )
Study First Received: August 31, 2007
Results First Received: August 23, 2013
Last Updated: March 14, 2016

Keywords provided by Roswell Park Cancer Institute:
adenocarcinoma of the esophagus
squamous cell carcinoma of the esophagus
stage I esophageal cancer
stage II esophageal cancer
stage III esophageal cancer
stage IV esophageal cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017