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A Phase II Study Of OSI-774 (NSC 718781) In Unresectable Or Metastatic Adenocarcinoma Of The Stomach And Gastroesophageal Junction


Phase 2
N/A
N/A
Not Enrolling
Both
Esophageal Cancer, Gastric Cancer

Thank you

Trial Information

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.)

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Tomislav Dragovich, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Arizona

Authority:

United States: Federal Government

Study ID:

CDR0000069259

NCT ID:

NCT00032123

Start Date:

June 2002

Completion Date:

May 2006

Related Keywords:

  • Esophageal Cancer
  • Gastric Cancer
  • stage IV gastric cancer
  • stage IV esophageal cancer
  • adenocarcinoma of the stomach
  • adenocarcinoma of the esophagus
  • recurrent esophageal cancer
  • recurrent gastric cancer
  • Adenocarcinoma
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms

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