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.
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00524121
First received: August 31, 2007
Last updated: October 28, 2011
Last verified: October 2011
  Purpose

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of study therapy on dysphagia control, performance status, and overall quality of life as assessed by FACT-E scale at baseline and periodically thereafter [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Correlation of smoking status with overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To correlate the EGFR and EGFR expression by IHC and EGFR mutation with clinical outcomes [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: March 2006
Study Completion Date: October 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: erlotinib hydrochloride
    Oral
    Other: immunohistochemistry staining method
    Correlative Study
    Radiation: radiation therapy
    Radiation Treatment
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 EGFR and phospho EGFR 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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00524121

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

Additional Information:
No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00524121     History of Changes
Other Study ID Numbers: CDR0000563268, RPCI-I-62705
Study First Received: August 31, 2007
Last Updated: October 28, 2011
Health Authority: United States: Food and Drug Administration

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
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014