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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00032123
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 24, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Gastric Cancer Drug: erlotinib hydrochloride Phase 2

Detailed Description:


  • 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.)

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Study Of OSI-774 (NSC 718781) In Unresectable Or Metastatic Adenocarcinoma Of The Stomach And Gastroesophageal Junction
Study Start Date : June 2002
Actual Study Completion Date : May 2006

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • Not specified

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • 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)


  • Creatinine no greater than 2 times ULN


  • No recent myocardial infarction
  • No unstable angina
  • No life-threatening arrhythmia


  • 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


  • 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


  • 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


Biologic therapy:

  • No prior biologic therapy
  • No concurrent anticancer immunotherapy


  • 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


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent anticancer radiotherapy


  • 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


  • No prior investigational drugs
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent anticancer therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00032123

  Show 107 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Tomislav Dragovich, MD, PhD University of Arizona

Publications of Results:
Dragovich T, McCoy S, Urba SG, et al.: SWOG 0127: phase II trial of erlotinib in GEJ and gastric adenocarcinomas. [Abstract] American Society of Clinical Oncology 2005 Gastrointestinal Cancers Symposium, 27-29 January 2005, Miami, Florida. A-49, 2005. Identifier: NCT00032123     History of Changes
Other Study ID Numbers: CDR0000069259
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 24, 2013
Last Verified: October 2003

Keywords provided by National Cancer Institute (NCI):
stage IV gastric cancer
stage IV esophageal cancer
adenocarcinoma of the stomach
adenocarcinoma of the esophagus
recurrent esophageal cancer
recurrent gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action