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Phase II Study Of OSI-774 In Advanced Esophageal Cancer

Phase 2
18 Years
Not Enrolling
Adenocarcinoma of the Esophagus, Adenocarcinoma of the Gastroesophageal Junction, Recurrent Esophageal Cancer, Squamous Cell Carcinoma of the Esophagus, Stage III Esophageal Cancer, Stage IV Esophageal Cancer

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Trial Information

Phase II Study Of OSI-774 In Advanced Esophageal Cancer


I. Determine the objective response rate in patients with advanced carcinoma of the
esophagus or gastroesophageal junction treated with erlotinib (erlotinib hydrochloride).

II. Determine the overall survival of patients treated with this drug. III. Determine the
degree of dysphagia relief in patients treated with this drug.

IV. Determine the toxicity and tolerability of this drug in these patients. V. Correlate
epidermal growth factor receptor (EGFR) expression with response to treatment in these


Patients receive erlotinib hydrochloride orally (PO) once daily (QD). Courses repeat every 4
weeks in the absence of disease progression or unacceptable toxicity.

Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma, squamous cell or small cell
carcinoma, or carcinoma not otherwise specified of the esophagus or gastroesophageal

- Metastatic or surgically unresectable disease

- Measurable disease outside of primary tumor

- At least 20 mm by conventional techniques OR at least 10 mm by spiral computed
tomography (CT) scan

- No bone metastases, abnormal radionuclide bone scans, or pleural effusions as only
site of measurable disease

- No known brain metastases or carcinomatous meningitis

- Must consent to having tumor tissue tested for epidermal growth factor receptor

- Performance status-Karnofsky 70-100%

- Life expectancy of greater than 3 months

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Bilirubin no greater than 2 times upper limit of normal (ULN)

- Aspartate aminotransferase (AST) no greater than 2 times ULN

- Creatinine no greater than 1.5 mg/dL

- Calcium no greater than 12 mg/dL

- No symptomatic hypercalcemia

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No ventricular arrhythmia

- No other malignancy within the past 3 years except adequately treated carcinoma in
situ of the cervix, superficial transitional cell carcinoma of the bladder, or basal
cell or squamous cell skin cancer

- No other uncontrolled concurrent illness

- No ongoing or active infection

- No psychiatric illness or social situation that would preclude study participation

- No other concurrent disease that would preclude study participation

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No prior cetuximab

- No more than 1 prior chemotherapy regimen for advanced or metastatic disease

- One prior chemotherapy in the adjuvant setting (in combination with prior surgery or
radiotherapy) allowed provided it was administered prior to treatment for advanced or
metastatic disease

- At least 3 weeks since prior chemotherapy

- No concurrent investigational or commercial chemotherapy

- At least 3 weeks since prior radiotherapy

- No prior erlotinib-related compounds or compounds of similar biologic or chemical

- No prior EGFR-targeting compounds (e.g., gefitinib)

- No other concurrent investigational agents

- No concurrent combination antiretroviral therapy for human immunodeficiency virus
(HIV)-positive patients

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Major response rate (complete and partial response)

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

David Ilson

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2002

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Esophagus
  • Adenocarcinoma of the Gastroesophageal Junction
  • Recurrent Esophageal Cancer
  • Squamous Cell Carcinoma of the Esophagus
  • Stage III Esophageal Cancer
  • Stage IV Esophageal Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Esophageal Diseases
  • Esophageal Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021