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Phase II Study of Erlotinib (Tarceva®) and Radiotherapy for Elderly Patients With Esophageal Carcinoma

Phase 2
65 Years
Not Enrolling
Esophageal Cancer

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Trial Information

Phase II Study of Erlotinib (Tarceva®) and Radiotherapy for Elderly Patients With Esophageal Carcinoma



- 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

- 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

Inclusion Criteria


- 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

- 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

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Renuka Iyer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

March 2006

Completion Date:

October 2011

Related Keywords:

  • Esophageal Cancer
  • 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
  • Esophageal Diseases
  • Esophageal Neoplasms



Roswell Park Cancer InstituteBuffalo, New York  14263