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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00524121
Recruitment Status : Completed
First Posted : September 3, 2007
Results First Posted : March 5, 2015
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Tracking Information
First Submitted Date  ICMJE August 31, 2007
First Posted Date  ICMJE September 3, 2007
Results First Submitted Date  ICMJE August 23, 2013
Results First Posted Date  ICMJE March 5, 2015
Last Update Posted Date April 14, 2016
Study Start Date  ICMJE March 2006
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2010)
Overall Survival [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2007)
Overall Survival
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2007)
  • Effect of therapy on dysphagia control, performance status, and overall quality of life by FACT-E scale before therapy, at week 3, 30 days after completion of radiotx, monthly for the remainder of drug admin., and 30 days after completion of therapy
  • Correlation of Smoking Status With Overall Survival
  • Correlation of expression of E-cadherin, P-cadherin, vimentin, cytokeratin, phospho-S6 and ki67 in tumor blocks with response by immunohistochemistry at baseline
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Erlotinib and Radiation Therapy in Treating Older Patients With Stage I, Stage II, Stage III, or Stage IV Esophageal Cancer
Official Title  ICMJE Phase II Study of Erlotinib (Tarceva®) and Radiotherapy for Elderly Patients With Esophageal Carcinoma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Esophageal Cancer
Intervention  ICMJE
  • Drug: erlotinib hydrochloride
    Oral
  • Other: immunohistochemistry staining method
    Correlative Study
  • Radiation: radiation therapy
    Radiation Treatment
Study Arms  ICMJE Experimental: Oral Erlotinib
Patients receive oral erlotinib hydrochloride once daily for 1 year
Interventions:
  • Drug: erlotinib hydrochloride
  • Other: immunohistochemistry staining method
  • Radiation: radiation therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2015)
22
Original Enrollment  ICMJE
 (submitted: August 31, 2007)
35
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • 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)

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 120 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00524121
Other Study ID Numbers  ICMJE CDR0000563268
RPCI-I-62705 ( Other Identifier: Roswell Park Cancer Institute )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roswell Park Cancer Institute
Study Sponsor  ICMJE Roswell Park Cancer Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Renuka Iyer, MD Roswell Park Cancer Institute
PRS Account Roswell Park Cancer Institute
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP