Erlotinib Hydrochloride in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer

Study Overview
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Brief Summary
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This phase II trial is studying erlotinib hydrochloride to see how well it works in treating patients with advanced esophageal cancer or stomach cancer. Erlotinib hydrochloride may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth.

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

Official Title
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Phase II Study Of OSI-774 In Advanced Esophageal Cancer

Conditions
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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

Intervention / Treatment
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* Drug: erlotinib hydrochloride
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma, squamous cell or small cell carcinoma, or carcinoma not otherwise specified of the esophagus or gastroesophageal junction 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 status 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 components 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (erlotinib hydrochloride)<br>Patients receive erlotinib hydrochloride PO QD. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. | Drug: erlotinib hydrochloride<br>* Given PO<br>* Other names: OSI-774;Other: laboratory biomarker analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major response rate (complete and partial response) |  | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicities, graded according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) |  | Up to 5 years | 
| Degree of dysphagia relief |  | Up to 5 years | 
| Time to progression | Estimated using the Kaplan-Meier method and confidence intervals will be formed for median time to progression. | Up to 5 years | 
| Overall survival | Estimated using the Kaplan-Meier method and confidence intervals will be formed for median survival time. | Up to 5 years |