|
Erlotinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer or Gastroesophageal Junction Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Erlotinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer or Gastroesophageal Junction Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Erlotinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer or Gastroesophageal Junction Cancer Clinical research trials and Erlotinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer or Gastroesophageal Junction Cancer healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Erlotinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer or Gastroesophageal Junction Cancer. Erlotinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer or Gastroesophageal Junction Cancer Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Erlotinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer or Gastroesophageal Junction Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Erlotinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer or Gastroesophageal Junction Cancer condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "E" Clinical Trials Conditions > Erlotinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer or Gastroesophageal Junction Cancer  Erlotinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
Erlotinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
For Condition: recurrent esophageal cancer,adenocarcinoma of the stomach,stage 4 esophageal cancer,recurrent gastric cancer,Adenocarcinoma of the Esophagus,stage 4 gastric cancer
Status: No longer recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.)
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TomislavDragovich, Study Chair, Arizona Cancer Center
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, 84148
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
CCOP - Greenville
Greenville, South Carolina, 29615
United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, 71130
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, 39534-2576
United States
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, 70112
United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, 87108-5138
United States
Veterans Affairs Medical Center - Long Beach
Long Beach, California, 90822
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503
United States
CCOP - Kansas City
Kansas City, Missouri, 64131
United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78229
United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, 48105
United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94143-0128
United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
United States
Veterans Affairs Medical Center - Temple
Temple, Texas, 76504
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, 29401-5799
United States
CCOP - Beaumont
Royal Oak, Michigan, 48073-6769
United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128
United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, 94553
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
United States
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905-5650
United States
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, 20060
United States
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, 90073
United States
CCOP - Northwest
Tacoma, Washington, 98405-0986
United States
David Grant Medical Center
Travis Air Force Base, California, 94535
United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218
United States
James P. Wilmot Cancer Center at the University of Rochester Medical Center
Rochester, New York, 14642
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4095
United States
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
Canada
Veterans Affairs Medical Center - Albany
Albany, New York, 12208
United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106
United States
Tripler Army Medical Center
Honolulu, Hawaii, 96859-5000
United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, 72205
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0912
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Western New York Urology Associates
Buffalo, New York, 14220
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97207
United States
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726
United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234-6200
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565
United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40502-2236
United States
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, 63141
United States
Veterans Affairs Medical Center - Dallas
Dallas, Texas, 75216
United States
CCOP - Columbia River Program
Portland, Oregon, 97225
United States
CCOP - Toledo Community Hospital
Toledo, Ohio, 43623-3456
United States
CCOP - Columbus
Columbus, Ohio, 43206
United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612-7323
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195-9001
United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, 45220-2288
United States
Veterans Affairs Medical Center - Houston
Houston, Texas, 77030
United States
Madigan Army Medical Center
Tacoma, Washington, 98431-5000
United States
Loyola University Medical Center
Maywood, Illinois, 60153-5500
United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
United States
Genesis Medical Center
Davenport, Iowa, 52804
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
St. Louis University Health Sciences Center
St. Louis, Missouri, 63110
United States
CCOP - Dayton
Dayton, Ohio, 45429
United States
Arizona Cancer Center
Tucson, Arizona, 85724
United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130
United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108
United States
Oregon Cancer Institute
Portland, Oregon, 97201-3098
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, 39216
United States
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7353
United States
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813-2424
United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723
United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, 48201-1932
United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, 73104
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5550
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-W227
United States
University of California Davis Cancer Center
Sacramento, California, 95817
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, 39531-2410
United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, 85012
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Barrett Cancer Center
Cincinnati, Ohio, 45267-0501
United States
University of Tennessee Cancer Institute
Memphis, Tennessee, 38103
United States
Providence Hospital - Southfield
Southfield, Michigan, 48075-9975
United States
Additional Information:
Study ID Numbers: CDR0000069259; SWOG-S0127
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00032123
Other Stage 4 Esophageal Cancer Studies:
1. Docetaxel and Epirubicin as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Adenocarcinoma of the Stomach
2. Bortezomib in Treating Patients With Unresectable or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
3. Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas or Stomach
4. Antineoplaston Therapy in Treating Patients With Stomach Cancer
5. Biological Therapy in Treating Patients With Advanced Cancer
Related Studies:
Other stage 4 esophageal cancer Clinical Trials
Other Arizona Clinical Trials
Other Phoenix Clinical Trials
Erlotinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
|
|
|
|
|
|
|
|
