- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00032123
Erlotinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
A Phase II Study Of OSI-774 (NSC 718781) In Unresectable Or Metastatic Adenocarcinoma Of The Stomach And Gastroesophageal Junction
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.)
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
- British Columbia Cancer Agency
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Alabama
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Mobile, Alabama, United States, 36688
- MBCCOP - Gulf Coast
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Arizona
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Phoenix, Arizona, United States, 85006-2726
- CCOP - Greater Phoenix
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Phoenix, Arizona, United States, 85012
- Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
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Tucson, Arizona, United States, 85724
- Arizona Cancer Center
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Tucson, Arizona, United States, 85723
- Veterans Affairs Medical Center - Tucson
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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Little Rock, Arkansas, United States, 72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
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California
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Duarte, California, United States, 91010
- City of Hope Comprehensive Cancer Center
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Long Beach, California, United States, 90822
- Veterans Affairs Medical Center - Long Beach
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Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, United States, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Los Angeles, California, United States, 90073
- Veterans Affairs Medical Center - West Los Angeles
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Martinez, California, United States, 94553
- Veterans Affairs Outpatient Clinic - Martinez
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Oakland, California, United States, 94609-3305
- CCOP - Bay Area Tumor Institute
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Orange, California, United States, 92868
- Chao Family Comprehensive Cancer Center
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Sacramento, California, United States, 95817
- University of California Davis Cancer Center
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San Francisco, California, United States, 94121
- Veterans Affairs Medical Center - San Francisco
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San Francisco, California, United States, 94143-0128
- UCSF Comprehensive Cancer Center
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Santa Rosa, California, United States, 95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base, California, United States, 94535
- David Grant Medical Center
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Colorado
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Denver, Colorado, United States, 80220
- Veterans Affairs Medical Center - Denver
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Denver, Colorado, United States, 80010
- University of Colorado Cancer Center
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District of Columbia
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Washington, District of Columbia, United States, 20060
- MBCCOP - Howard University Cancer Center
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Florida
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Jacksonville, Florida, United States, 32224
- Mayo Clinic
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Georgia
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Atlanta, Georgia, United States, 30342-1701
- CCOP - Atlanta Regional
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Fort Gordon, Georgia, United States, 30905-5650
- Dwight David Eisenhower Army Medical Center
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Hawaii
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Honolulu, Hawaii, United States, 96859-5000
- Tripler Army Medical Center
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Honolulu, Hawaii, United States, 96813-2424
- Cancer Research Center of Hawaii
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Illinois
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Chicago, Illinois, United States, 60612-7323
- MBCCOP - University of Illinois at Chicago
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Chicago, Illinois, United States, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Chicago, Illinois, United States, 60611-W227
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
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Decatur, Illinois, United States, 62526
- CCOP - Central Illinois
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Hines, Illinois, United States, 60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
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Maywood, Illinois, United States, 60153-5500
- Loyola University Medical Center
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Iowa
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Davenport, Iowa, United States, 52804
- Genesis Medical Center
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Kansas
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Kansas City, Kansas, United States, 66160-7353
- University of Kansas Medical Center
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Wichita, Kansas, United States, 67214-3882
- CCOP - Wichita
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Wichita, Kansas, United States, 67218
- Veterans Affairs Medical Center - Wichita
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Kentucky
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Lexington, Kentucky, United States, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Lexington, Kentucky, United States, 40502-2236
- Veterans Affairs Medical Center - Lexington
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, United States, 70112
- Veterans Affairs Medical Center - New Orleans
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New Orleans, Louisiana, United States, 70112
- MBCCOP - LSU Health Sciences Center
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Shreveport, Louisiana, United States, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Shreveport, Louisiana, United States, 71130
- Veterans Affairs Medical Center - Shreveport
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
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Jamaica Plain, Massachusetts, United States, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, United States, 48105
- Veterans Affairs Medical Center - Ann Arbor
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Ann Arbor, Michigan, United States, 48106
- CCOP - Michigan Cancer Research Consortium
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Ann Arbor, Michigan, United States, 48109-0912
- University of Michigan Comprehensive Cancer Center
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital
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Detroit, Michigan, United States, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, United States, 48201-1932
- Veterans Affairs Medical Center - Detroit
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Grand Rapids, Michigan, United States, 49503
- CCOP - Grand Rapids
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Royal Oak, Michigan, United States, 48073-6769
- CCOP - Beaumont
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Southfield, Michigan, United States, 48075-9975
- Providence Hospital - Southfield
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Mississippi
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Biloxi, Mississippi, United States, 39531-2410
- Veterans Affairs Medical Center - Biloxi
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Jackson, Mississippi, United States, 39216-4505
- University of Mississippi Medical Center
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Jackson, Mississippi, United States, 39216
- Veterans Affairs Medical Center - Jackson
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Keesler AFB, Mississippi, United States, 39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Kansas City, Missouri, United States, 64128
- Veterans Affairs Medical Center - Kansas City
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Kansas City, Missouri, United States, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, United States, 63141
- CCOP - St. Louis-Cape Girardeau
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Saint Louis, Missouri, United States, 63110
- St. Louis University Health Sciences Center
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Springfield, Missouri, United States, 65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings, Montana, United States, 59101
- CCOP - Montana Cancer Consortium
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New Mexico
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Albuquerque, New Mexico, United States, 87108-5138
- Veterans Affairs Medical Center - Albuquerque
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Albuquerque, New Mexico, United States, 87131
- MBCCOP - University of New Mexico HSC
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New York
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Albany, New York, United States, 12208
- Veterans Affairs Medical Center - Albany
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Buffalo, New York, United States, 14220
- Western New York Urology Associates
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New York, New York, United States, 10032
- Herbert Irving Comprehensive Cancer Center
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Rochester, New York, United States, 14642
- James P. Wilmot Cancer Center at the University of Rochester Medical Center
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North Carolina
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Winston-Salem, North Carolina, United States, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Ohio
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Cincinnati, Ohio, United States, 45220-2288
- Veterans Affairs Medical Center - Cincinnati
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Cincinnati, Ohio, United States, 45267-0501
- Barrett Cancer Center
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Cleveland, Ohio, United States, 44195-9001
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, United States, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Columbus, Ohio, United States, 43206
- CCOP - Columbus
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Dayton, Ohio, United States, 45428
- Veterans Affairs Medical Center - Dayton
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Dayton, Ohio, United States, 45429
- CCOP - Dayton
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Toledo, Ohio, United States, 43623-3456
- CCOP - Toledo Community Hospital
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma Health Sciences Center
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Oklahoma City, Oklahoma, United States, 73104
- Veterans Affairs Medical Center - Oklahoma City
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Oregon
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Portland, Oregon, United States, 97207
- Veterans Affairs Medical Center - Portland
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Portland, Oregon, United States, 97225
- CCOP - Columbia River Program
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Portland, Oregon, United States, 97201-3098
- Oregon Cancer Institute
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South Carolina
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Charleston, South Carolina, United States, 29425-0721
- Medical University of South Carolina
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Charleston, South Carolina, United States, 29401-5799
- Veterans Affairs Medical Center - Charleston
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Greenville, South Carolina, United States, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, United States, 29303
- CCOP - Upstate Carolina
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Tennessee
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Memphis, Tennessee, United States, 38103
- University of Tennessee Cancer Institute
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Texas
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Dallas, Texas, United States, 75216
- Veterans Affairs Medical Center - Dallas
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Fort Sam Houston, Texas, United States, 78234-6200
- Brooke Army Medical Center
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Galveston, Texas, United States, 77555-0565
- University of Texas Medical Branch
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Houston, Texas, United States, 77030
- Veterans Affairs Medical Center - Houston
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Houston, Texas, United States, 77030-4095
- University of Texas - MD Anderson Cancer Center
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San Antonio, Texas, United States, 78229-3900
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, United States, 78229
- Veterans Affairs Medical Center - San Antonio (Murphy)
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Temple, Texas, United States, 76504
- Veterans Affairs Medical Center - Temple
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Temple, Texas, United States, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, United States, 84148
- Veterans Affairs Medical Center - Salt Lake City
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Salt Lake City, Utah, United States, 84112-5550
- Huntsman Cancer Institute
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Washington
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Seattle, Washington, United States, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, United States, 98108
- Veterans Affairs Medical Center - Seattle
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Tacoma, Washington, United States, 98431-5000
- Madigan Army Medical Center
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Tacoma, Washington, United States, 98405-0986
- CCOP - Northwest
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Tomislav Dragovich, MD, PhD, University of Arizona
Publications and helpful links
General Publications
- Dragovich T, McCoy S, Fenoglio-Preiser CM, Wang J, Benedetti JK, Baker AF, Hackett CB, Urba SG, Zaner KS, Blanke CD, Abbruzzese JL. Phase II trial of erlotinib in gastroesophageal junction and gastric adenocarcinomas: SWOG 0127. J Clin Oncol. 2006 Oct 20;24(30):4922-7. doi: 10.1200/JCO.2006.07.1316. Erratum In: J Clin Oncol. 2007 Jun 1;25(16):2334.
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Stomach Neoplasms
- Esophageal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Erlotinib Hydrochloride
Other Study ID Numbers
- CDR0000069259
- SWOG-S0127
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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