Gastric Cancer Clinical Trial
Official title:
A Phase II Study Of OSI-774 (NSC 718781) In Unresectable Or Metastatic Adenocarcinoma Of The Stomach And Gastroesophageal Junction
Verified date | October 2003 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | May 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | British Columbia Cancer Agency | Vancouver | British Columbia |
United States | Veterans Affairs Medical Center - Albany | Albany | New York |
United States | MBCCOP - University of New Mexico HSC | Albuquerque | New Mexico |
United States | Veterans Affairs Medical Center - Albuquerque | Albuquerque | New Mexico |
United States | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan |
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | Veterans Affairs Medical Center - Ann Arbor | Ann Arbor | Michigan |
United States | CCOP - Atlanta Regional | Atlanta | Georgia |
United States | CCOP - Montana Cancer Consortium | Billings | Montana |
United States | Veterans Affairs Medical Center - Biloxi | Biloxi | Mississippi |
United States | Boston Medical Center | Boston | Massachusetts |
United States | Western New York Urology Associates | Buffalo | New York |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Veterans Affairs Medical Center - Charleston | Charleston | South Carolina |
United States | MBCCOP - University of Illinois at Chicago | Chicago | Illinois |
United States | Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago | Illinois |
United States | Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago | Illinois |
United States | Barrett Cancer Center | Cincinnati | Ohio |
United States | Veterans Affairs Medical Center - Cincinnati | Cincinnati | Ohio |
United States | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio |
United States | Arthur G. James Cancer Hospital - Ohio State University | Columbus | Ohio |
United States | CCOP - Columbus | Columbus | Ohio |
United States | Veterans Affairs Medical Center - Dallas | Dallas | Texas |
United States | Genesis Medical Center | Davenport | Iowa |
United States | CCOP - Dayton | Dayton | Ohio |
United States | Veterans Affairs Medical Center - Dayton | Dayton | Ohio |
United States | CCOP - Central Illinois | Decatur | Illinois |
United States | University of Colorado Cancer Center | Denver | Colorado |
United States | Veterans Affairs Medical Center - Denver | Denver | Colorado |
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Veterans Affairs Medical Center - Detroit | Detroit | Michigan |
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
United States | Dwight David Eisenhower Army Medical Center | Fort Gordon | Georgia |
United States | Brooke Army Medical Center | Fort Sam Houston | Texas |
United States | University of Texas Medical Branch | Galveston | Texas |
United States | CCOP - Grand Rapids | Grand Rapids | Michigan |
United States | CCOP - Greenville | Greenville | South Carolina |
United States | Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines | Illinois |
United States | Cancer Research Center of Hawaii | Honolulu | Hawaii |
United States | Tripler Army Medical Center | Honolulu | Hawaii |
United States | University of Texas - MD Anderson Cancer Center | Houston | Texas |
United States | Veterans Affairs Medical Center - Houston | Houston | Texas |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Veterans Affairs Medical Center - Jackson | Jackson | Mississippi |
United States | Mayo Clinic | Jacksonville | Florida |
United States | Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain | Massachusetts |
United States | CCOP - Kansas City | Kansas City | Missouri |
United States | University of Kansas Medical Center | Kansas City | Kansas |
United States | Veterans Affairs Medical Center - Kansas City | Kansas City | Missouri |
United States | Keesler Medical Center - Keesler AFB | Keesler AFB | Mississippi |
United States | Albert B. Chandler Medical Center, University of Kentucky | Lexington | Kentucky |
United States | Veterans Affairs Medical Center - Lexington | Lexington | Kentucky |
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | Veterans Affairs Medical Center - Little Rock (McClellan) | Little Rock | Arkansas |
United States | Veterans Affairs Medical Center - Long Beach | Long Beach | California |
United States | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California |
United States | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California |
United States | Veterans Affairs Medical Center - West Los Angeles | Los Angeles | California |
United States | Veterans Affairs Outpatient Clinic - Martinez | Martinez | California |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | University of Tennessee Cancer Institute | Memphis | Tennessee |
United States | MBCCOP - Gulf Coast | Mobile | Alabama |
United States | MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana |
United States | Tulane University School of Medicine | New Orleans | Louisiana |
United States | Veterans Affairs Medical Center - New Orleans | New Orleans | Louisiana |
United States | Herbert Irving Comprehensive Cancer Center | New York | New York |
United States | CCOP - Bay Area Tumor Institute | Oakland | California |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Veterans Affairs Medical Center - Oklahoma City | Oklahoma City | Oklahoma |
United States | Chao Family Comprehensive Cancer Center | Orange | California |
United States | CCOP - Greater Phoenix | Phoenix | Arizona |
United States | Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) | Phoenix | Arizona |
United States | CCOP - Columbia River Program | Portland | Oregon |
United States | Oregon Cancer Institute | Portland | Oregon |
United States | Veterans Affairs Medical Center - Portland | Portland | Oregon |
United States | James P. Wilmot Cancer Center at the University of Rochester Medical Center | Rochester | New York |
United States | CCOP - Beaumont | Royal Oak | Michigan |
United States | University of California Davis Cancer Center | Sacramento | California |
United States | CCOP - St. Louis-Cape Girardeau | Saint Louis | Missouri |
United States | St. Louis University Health Sciences Center | Saint Louis | Missouri |
United States | Huntsman Cancer Institute | Salt Lake City | Utah |
United States | Veterans Affairs Medical Center - Salt Lake City | Salt Lake City | Utah |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio | Texas |
United States | UCSF Comprehensive Cancer Center | San Francisco | California |
United States | Veterans Affairs Medical Center - San Francisco | San Francisco | California |
United States | CCOP - Santa Rosa Memorial Hospital | Santa Rosa | California |
United States | CCOP - Virginia Mason Research Center | Seattle | Washington |
United States | Veterans Affairs Medical Center - Seattle | Seattle | Washington |
United States | Louisiana State University Health Sciences Center - Shreveport | Shreveport | Louisiana |
United States | Veterans Affairs Medical Center - Shreveport | Shreveport | Louisiana |
United States | Providence Hospital - Southfield | Southfield | Michigan |
United States | CCOP - Upstate Carolina | Spartanburg | South Carolina |
United States | CCOP - Cancer Research for the Ozarks | Springfield | Missouri |
United States | CCOP - Northwest | Tacoma | Washington |
United States | Madigan Army Medical Center | Tacoma | Washington |
United States | CCOP - Scott and White Hospital | Temple | Texas |
United States | Veterans Affairs Medical Center - Temple | Temple | Texas |
United States | CCOP - Toledo Community Hospital | Toledo | Ohio |
United States | David Grant Medical Center | Travis Air Force Base | California |
United States | Arizona Cancer Center | Tucson | Arizona |
United States | Veterans Affairs Medical Center - Tucson | Tucson | Arizona |
United States | MBCCOP - Howard University Cancer Center | Washington | District of Columbia |
United States | CCOP - Wichita | Wichita | Kansas |
United States | Veterans Affairs Medical Center - Wichita | Wichita | Kansas |
United States | CCOP - Southeast Cancer Control Consortium | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Southwest Oncology Group | National Cancer Institute (NCI) |
United States, Canada,
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; — View Citation
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.
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