Erlotinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer or Gastroesophageal Junction Cancer

Study Overview
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Brief Summary
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RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have locally advanced or metastatic stomach cancer or cancer of the gastroesophageal junction.

Detailed Description
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OBJECTIVES: Determine the overall response rate of patients with locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with erlotinib. (Gastric stratum temporarily closed to accrual as of 03/01/2003.) Determine the frequency and severity of toxic effects of this drug in these patients. Determine the overall survival and time to treatment failure in patients treated with this drug. Determine the value of intratumoral expression of epidermal growth factor receptor in predicting patient response to this drug. OUTLINE: This is a multicenter study. Patients are stratified according to cancer site (stomach vs gastroesophageal junction). (The gastric stratum is temporarily closed to accrual as of 03-01-2003.) Patients receive oral erlotinib once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 3 years. PROJECTED ACCRUAL: A total of 40-80 patients (20-40 per stratum) will be accrued for this study within 14-40 months. (The gastric stratum is temporarily closed to accrual as of 03-01-2003.)

Official Title
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A Phase II Study Of OSI-774 (NSC 718781) In Unresectable Or Metastatic Adenocarcinoma Of The Stomach And Gastroesophageal Junction

Conditions
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Esophageal Cancer, Gastric Cancer

Intervention / Treatment
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* Drug: erlotinib hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the stomach* or gastroesophageal (GE) junction GE junction tumors include esophageal tumors arising 5 cm from the anatomic GE junction or in the gastric cardia Locally advanced (i.e., unresectable) or metastatic disease NOTE: *Gastric stratum temporarily closed to accrual as of 03/01/2003 Unidimensionally measurable disease Target lesion must not be in previously irradiated field unless there is documentation of clear progression No known brain metastases PATIENT CHARACTERISTICS: Age: Not specified Performance status: Zubrod 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT or SGPT no greater than 1.5 times ULN (5 times ULN if liver metastases present) Renal: Creatinine no greater than 2 times ULN Cardiovascular: No recent myocardial infarction No unstable angina No life-threatening arrhythmia Gastrointestinal: No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation No active peptic ulcer disease Must be able to swallow and/or receive enteral medications via gastrostomy feeding tube No intractable nausea or vomiting Ophthalmic: No history of corneal disease, including: Dry eye syndrome or Sjögren's syndrome Keratoconjunctivitis sicca Exposure keratopathy Fuch's dystrophy Other active disorders of the cornea Other: HIV negative No active or uncontrolled infection No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission No severe psychiatric disorders Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy No concurrent anticancer immunotherapy Chemotherapy: No prior chemotherapy for advanced or metastatic gastric cancer At least 8 weeks since prior adjuvant chemotherapy or chemotherapy given as a radiosensitizer and recovered No concurrent anticancer chemotherapy Endocrine therapy: No concurrent anticancer hormonal therapy Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No concurrent anticancer radiotherapy Surgery: At least 4 weeks since prior surgical procedure for stomach* or GE cancer and recovered No prior surgical procedures that would affect absorption NOTE: *Gastric stratum temporarily closed to accrual as of 03/01/2003 Other: No prior investigational drugs No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent anticancer therapy
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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: erlotinib hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV gastric cancer, stage IV esophageal cancer, adenocarcinoma of the stomach, adenocarcinoma of the esophagus, recurrent esophageal cancer, recurrent gastric cancer