A Phase II Study Of OSI-774 (NSC 718781) In Unresectable Or Metastatic Adenocarcinoma Of The Stomach And Gastroesophageal Junction
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.)
Interventional
Primary Purpose: Treatment
Tomislav Dragovich, MD, PhD
Study Chair
University of Arizona
United States: Federal Government
CDR0000069259
NCT00032123
June 2002
May 2006
Name | Location |
---|---|
Arizona Cancer Center | Tucson, Arizona 85724 |
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
Chao Family Comprehensive Cancer Center | Orange, California 92868 |
University of Colorado Cancer Center | Denver, Colorado 80262 |
Albert B. Chandler Medical Center, University of Kentucky | Lexington, Kentucky 40536-0084 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
Tripler Army Medical Center | Honolulu, Hawaii 96859-5000 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
CCOP - Greater Phoenix | Phoenix, Arizona 85006-2726 |
CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Loyola University Medical Center | Maywood, Illinois 60153 |
Henry Ford Hospital | Detroit, Michigan 48202 |
Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
Veterans Affairs Medical Center - Long Beach | Long Beach, California 90822 |
Veterans Affairs Outpatient Clinic - Martinez | Martinez, California 94553 |
CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California 95403 |
David Grant Medical Center | Travis Air Force Base, California 94535 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
Veterans Affairs Medical Center - Lexington | Lexington, Kentucky 40511-1093 |
Tulane University School of Medicine | New Orleans, Louisiana 70112 |
Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain, Massachusetts 02130 |
Veterans Affairs Medical Center - Ann Arbor | Ann Arbor, Michigan 48105 |
St. Louis University Health Sciences Center | Saint Louis, Missouri 63110-0250 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
Veterans Affairs Medical Center - Albany | Albany, New York 12208 |
CCOP - Columbus | Columbus, Ohio 43206 |
Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
CCOP - Dayton | Kettering, Ohio 45429 |
CCOP - Columbia River Program | Portland, Oregon 97213 |
CCOP - Greenville | Greenville, South Carolina 29615 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
MBCCOP - University of Illinois at Chicago | Chicago, Illinois 60612 |
CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
MBCCOP - University of New Mexico HSC | Albuquerque, New Mexico 87131 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
MBCCOP - Gulf Coast | Mobile, Alabama 36688 |
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) | Phoenix, Arizona 85012 |
Veterans Affairs Medical Center - Tucson | Tucson, Arizona 85723 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Veterans Affairs Medical Center - Little Rock (McClellan) | Little Rock, Arkansas 72205 |
Veterans Affairs Medical Center - West Los Angeles | Los Angeles, California 90073 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
Dwight David Eisenhower Army Medical Center | Fort Gordon, Georgia 30905-5650 |
Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago, Illinois 60612 |
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines, Illinois 60141 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Veterans Affairs Medical Center - Wichita | Wichita, Kansas 67218 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
Louisiana State University Health Sciences Center - Shreveport | Shreveport, Louisiana 71130-3932 |
Veterans Affairs Medical Center - Shreveport | Shreveport, Louisiana 71130 |
Boston Medical Center | Boston, Massachusetts 02118 |
Veterans Affairs Medical Center - Detroit | Detroit, Michigan 48201-1932 |
Providence Hospital - Southfield | Southfield, Michigan 48075-9975 |
Veterans Affairs Medical Center - Biloxi | Biloxi, Mississippi 39531-2410 |
Veterans Affairs Medical Center - Jackson | Jackson, Mississippi 39216 |
Keesler Medical Center - Keesler AFB | Keesler AFB, Mississippi 39534-2576 |
Veterans Affairs Medical Center - Kansas City | Kansas City, Missouri 64128 |
CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
Veterans Affairs Medical Center - Albuquerque | Albuquerque, New Mexico 87108-5138 |
Herbert Irving Comprehensive Cancer Center | New York, New York 10032 |
Veterans Affairs Medical Center - Cincinnati | Cincinnati, Ohio 45220-2288 |
Veterans Affairs Medical Center - Oklahoma City | Oklahoma City, Oklahoma 73104 |
Veterans Affairs Medical Center - Portland | Portland, Oregon 97207 |
Veterans Affairs Medical Center - Charleston | Charleston, South Carolina 29401-5799 |
Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
Veterans Affairs Medical Center - Houston | Houston, Texas 77030 |
Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio, Texas 78284 |
Veterans Affairs Medical Center - Temple | Temple, Texas 76504 |
Veterans Affairs Medical Center - Salt Lake City | Salt Lake City, Utah 84148 |
CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
Veterans Affairs Medical Center - Seattle | Seattle, Washington 98108 |
CCOP - Northwest | Tacoma, Washington 98405-0986 |
Madigan Army Medical Center | Tacoma, Washington 98431-5048 |
Veterans Affairs Medical Center - New Orleans | New Orleans, Louisiana 70112 |
Veterans Affairs Medical Center - San Francisco | San Francisco, California 94121 |
University of California Davis Cancer Center | Sacramento, California 95817 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
Oregon Cancer Institute | Portland, Oregon 97201-3098 |
University of Tennessee Cancer Institute | Memphis, Tennessee 38103 |
Veterans Affairs Medical Center - Dallas | Dallas, Texas 75216 |
CCOP - Beaumont | Royal Oak, Michigan 48073-6769 |
Barrett Cancer Center | Cincinnati, Ohio 45267-0502 |
CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
MBCCOP - Howard University Cancer Center | Washington, District of Columbia 20060 |
Mayo Clinic | Jacksonville, Florida 32224 |
Western New York Urology Associates | Buffalo, New York 14220 |
Genesis Medical Center | Davenport, Iowa 52804 |
James P. Wilmot Cancer Center at the University of Rochester Medical Center | Rochester, New York 14642 |