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

Sponsor
Southwest Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00032123
Collaborator
National Cancer Institute (NCI) (NIH)
107
Locations
47
Duration (Months)

Study Details

Study Description

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
  • Drug: erlotinib hydrochloride
 Phase 2

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 Design

Study Type:
Interventional
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 :
Jun 1, 2002
Actual Study Completion Date :
May 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MBCCOP - Gulf Coast Mobile Alabama United States 36688
    2 CCOP - Greater Phoenix Phoenix Arizona United States 85006-2726
    3 Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) Phoenix Arizona United States 85012
    4 Veterans Affairs Medical Center - Tucson Tucson Arizona United States 85723
    5 Arizona Cancer Center Tucson Arizona United States 85724
    6 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    7 Veterans Affairs Medical Center - Little Rock (McClellan) Little Rock Arkansas United States 72205
    8 City of Hope Comprehensive Cancer Center Duarte California United States 91010
    9 Veterans Affairs Medical Center - Long Beach Long Beach California United States 90822
    10 USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California United States 90033-0804
    11 Veterans Affairs Medical Center - West Los Angeles Los Angeles California United States 90073
    12 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781
    13 Veterans Affairs Outpatient Clinic - Martinez Martinez California United States 94553
    14 CCOP - Bay Area Tumor Institute Oakland California United States 94609-3305
    15 Chao Family Comprehensive Cancer Center Orange California United States 92868
    16 University of California Davis Cancer Center Sacramento California United States 95817
    17 Veterans Affairs Medical Center - San Francisco San Francisco California United States 94121
    18 UCSF Comprehensive Cancer Center San Francisco California United States 94143-0128
    19 CCOP - Santa Rosa Memorial Hospital Santa Rosa California United States 95403
    20 David Grant Medical Center Travis Air Force Base California United States 94535
    21 University of Colorado Cancer Center Denver Colorado United States 80010
    22 Veterans Affairs Medical Center - Denver Denver Colorado United States 80220
    23 MBCCOP - Howard University Cancer Center Washington District of Columbia United States 20060
    24 Mayo Clinic Jacksonville Florida United States 32224
    25 CCOP - Atlanta Regional Atlanta Georgia United States 30342-1701
    26 Dwight David Eisenhower Army Medical Center Fort Gordon Georgia United States 30905-5650
    27 Cancer Research Center of Hawaii Honolulu Hawaii United States 96813-2424
    28 Tripler Army Medical Center Honolulu Hawaii United States 96859-5000
    29 Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago Illinois United States 60611-W227
    30 MBCCOP - University of Illinois at Chicago Chicago Illinois United States 60612-7323
    31 Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago Illinois United States 60612
    32 CCOP - Central Illinois Decatur Illinois United States 62526
    33 Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) Hines Illinois United States 60141
    34 Loyola University Medical Center Maywood Illinois United States 60153-5500
    35 Genesis Medical Center Davenport Iowa United States 52804
    36 University of Kansas Medical Center Kansas City Kansas United States 66160-7353
    37 CCOP - Wichita Wichita Kansas United States 67214-3882
    38 Veterans Affairs Medical Center - Wichita Wichita Kansas United States 67218
    39 Veterans Affairs Medical Center - Lexington Lexington Kentucky United States 40502-2236
    40 Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky United States 40536-0084
    41 MBCCOP - LSU Health Sciences Center New Orleans Louisiana United States 70112
    42 Tulane University School of Medicine New Orleans Louisiana United States 70112
    43 Veterans Affairs Medical Center - New Orleans New Orleans Louisiana United States 70112
    44 Louisiana State University Health Sciences Center - Shreveport Shreveport Louisiana United States 71130-3932
    45 Veterans Affairs Medical Center - Shreveport Shreveport Louisiana United States 71130
    46 Boston Medical Center Boston Massachusetts United States 02118
    47 Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain Massachusetts United States 02130
    48 Veterans Affairs Medical Center - Ann Arbor Ann Arbor Michigan United States 48105
    49 CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan United States 48106
    50 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109-0912
    51 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201-1379
    52 Veterans Affairs Medical Center - Detroit Detroit Michigan United States 48201-1932
    53 Henry Ford Hospital Detroit Michigan United States 48202
    54 CCOP - Grand Rapids Grand Rapids Michigan United States 49503
    55 CCOP - Beaumont Royal Oak Michigan United States 48073-6769
    56 Providence Hospital - Southfield Southfield Michigan United States 48075-9975
    57 Veterans Affairs Medical Center - Biloxi Biloxi Mississippi United States 39531-2410
    58 University of Mississippi Medical Center Jackson Mississippi United States 39216-4505
    59 Veterans Affairs Medical Center - Jackson Jackson Mississippi United States 39216
    60 Keesler Medical Center - Keesler AFB Keesler AFB Mississippi United States 39534-2576
    61 Veterans Affairs Medical Center - Kansas City Kansas City Missouri United States 64128
    62 CCOP - Kansas City Kansas City Missouri United States 64131
    63 St. Louis University Health Sciences Center Saint Louis Missouri United States 63110
    64 CCOP - St. Louis-Cape Girardeau Saint Louis Missouri United States 63141
    65 CCOP - Cancer Research for the Ozarks Springfield Missouri United States 65807
    66 CCOP - Montana Cancer Consortium Billings Montana United States 59101
    67 Veterans Affairs Medical Center - Albuquerque Albuquerque New Mexico United States 87108-5138
    68 MBCCOP - University of New Mexico HSC Albuquerque New Mexico United States 87131
    69 Veterans Affairs Medical Center - Albany Albany New York United States 12208
    70 Western New York Urology Associates Buffalo New York United States 14220
    71 Herbert Irving Comprehensive Cancer Center New York New York United States 10032
    72 James P. Wilmot Cancer Center at the University of Rochester Medical Center Rochester New York United States 14642
    73 CCOP - Southeast Cancer Control Consortium Winston-Salem North Carolina United States 27104-4241
    74 Veterans Affairs Medical Center - Cincinnati Cincinnati Ohio United States 45220-2288
    75 Barrett Cancer Center Cincinnati Ohio United States 45267-0501
    76 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195-9001
    77 CCOP - Columbus Columbus Ohio United States 43206
    78 Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio United States 43210-1240
    79 Veterans Affairs Medical Center - Dayton Dayton Ohio United States 45428
    80 CCOP - Dayton Dayton Ohio United States 45429
    81 CCOP - Toledo Community Hospital Toledo Ohio United States 43623-3456
    82 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    83 Veterans Affairs Medical Center - Oklahoma City Oklahoma City Oklahoma United States 73104
    84 Oregon Cancer Institute Portland Oregon United States 97201-3098
    85 Veterans Affairs Medical Center - Portland Portland Oregon United States 97207
    86 CCOP - Columbia River Program Portland Oregon United States 97225
    87 Veterans Affairs Medical Center - Charleston Charleston South Carolina United States 29401-5799
    88 Medical University of South Carolina Charleston South Carolina United States 29425-0721
    89 CCOP - Greenville Greenville South Carolina United States 29615
    90 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
    91 University of Tennessee Cancer Institute Memphis Tennessee United States 38103
    92 Veterans Affairs Medical Center - Dallas Dallas Texas United States 75216
    93 Brooke Army Medical Center Fort Sam Houston Texas United States 78234-6200
    94 University of Texas Medical Branch Galveston Texas United States 77555-0565
    95 University of Texas - MD Anderson Cancer Center Houston Texas United States 77030-4095
    96 Veterans Affairs Medical Center - Houston Houston Texas United States 77030
    97 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229-3900
    98 Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio Texas United States 78229
    99 Veterans Affairs Medical Center - Temple Temple Texas United States 76504
    100 CCOP - Scott and White Hospital Temple Texas United States 76508
    101 Huntsman Cancer Institute Salt Lake City Utah United States 84112-5550
    102 Veterans Affairs Medical Center - Salt Lake City Salt Lake City Utah United States 84148
    103 CCOP - Virginia Mason Research Center Seattle Washington United States 98101
    104 Veterans Affairs Medical Center - Seattle Seattle Washington United States 98108
    105 CCOP - Northwest Tacoma Washington United States 98405-0986
    106 Madigan Army Medical Center Tacoma Washington United States 98431-5000
    107 British Columbia Cancer Agency Vancouver British Columbia Canada V5Z 4E6

    Sponsors and Collaborators

    • Southwest Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Tomislav Dragovich, MD, PhD, University of Arizona

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00032123
    Other Study ID Numbers:
    • CDR0000069259
    • SWOG-S0127
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jun 24, 2013
    Last Verified:
    Oct 1, 2003
    Keywords provided by , ,
    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
    Erlotinib Hydrochloride

    Study Results

    No Results Posted as of Jun 24, 2013