|
Gefitinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Gefitinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Gefitinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Clinical research trials and Gefitinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Gefitinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer. Gefitinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Gefitinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their Gefitinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "G" Clinical Trials Conditions > Gefitinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer  Gefitinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Gefitinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
For Condition: bronchoalveolar cell lung cancer,stage 4 non-small cell lung cancer,stage 3B non-small cell lung cancer,recurrent non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of non-small cell lung cancer. PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
Details: OBJECTIVES: - Determine the 1-year survival, progression-free survival, and overall survival in patients with stage IIIB or IV bronchoalveolar carcinoma treated with gefitinib. - Determine the frequency and severity of toxic effects of this drug in these patients. - Determine the response rate in patients with measurable disease treated with this drug. - Correlate epidermal growth factor receptor (EGFR) and EGFR variant III overexpression with clinical outcome in patients treated with this drug. OUTLINE: This is a multicenter study. Patients are stratified according to prior systemic treatment for bronchoalveolar carcinoma (yes vs no). (The previously untreated stratum closed to accrual as of 2/15/2003.) Patients receive oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 2 years and then annually thereafter. PROJECTED ACCRUAL: A total of 90 patients (55 for the previously untreated stratum and 35 for the previously treated stratum) will be accrued for this study within 24 months. (The previously untreated stratum closed to accrual as of 2/15/2003.)
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed bronchoalveolar carcinoma - No fine needle aspirates or bronchial brushings or washings - Multi-focal or diffuse tumors - Stage IIIB disease due to cytologically confirmed malignant pleural effusion OR - Stage IV disease - Evidence of disease by CT scan of chest - Incompletely resected or unresectable disease - No known brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Zubrod 0-2 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - WBC at least 3,000/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 2.5 times ULN (5 times ULN if liver metastases present) - Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if bone metastases present) Renal: - Not specified Cardiovascular: - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No uncontrolled concurrent illness - No ongoing or active infection - No gastrointestinal tract disease that would preclude oral medication intake or cause requirement for IV alimentation - No corneal inflammation or infection - No psychiatric illness or social situation that would preclude study compliance - No other prior 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 in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior biologic therapy - No prior biologic therapy that targets epidermal growth factor receptor Chemotherapy: - At least 4 weeks since prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior radiotherapy - No prior radiotherapy to areas of assessable disease Surgery: - See Disease Characteristics - Recovered from prior surgery - No prior surgical procedure affecting gastrointestinal absorption Other: - No other concurrent therapy for bronchoalveolar carcinoma - No other concurrent investigational agents - No concurrent agents that induce CYP3A4 (e.g., nafcillin, rifampin, carbamazepine, phenobarbital, phenytoin, and St. John's Wort)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HowardWest, Study Chair, Swedish Cancer Institute - First Hill Campus
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, 63141
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, 71130
United States
Veterans Affairs Medical Center - Temple
Temple, Texas, 76504
United States
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, 70112
United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905-5650
United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
United States
MBCCOP - LSU Medical Center
New Orleans, Louisiana, 70112
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, 73104
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4095
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612-7323
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220
United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130
United States
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, 20060
United States
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503
United States
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, 39534-2576
United States
Barrett Cancer Center
Cincinnati, Ohio, 45267-0501
United States
Tripler Army Medical Center
Honolulu, Hawaii, 96859-5000
United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40502-2236
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7353
United States
Veterans Affairs Medical Center - Houston
Houston, Texas, 77030
United States
Arizona Cancer Center
Tucson, Arizona, 85724
United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, 72205
United States
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, 90073
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108
United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
David Grant Medical Center
Travis Air Force Base, California, 94535
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
United States
CCOP - Dayton
Dayton, Ohio, 45429
United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
United States
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726
United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, 85012
United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, 48105
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5550
United States
CCOP - Columbus
Columbus, Ohio, 43206
United States
Loyola University Medical Center
Maywood, Illinois, 60153-5500
United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128
United States
Oregon Cancer Institute
Portland, Oregon, 97239
United States
University of Tennessee Cancer Institute
Memphis, Tennessee, 38103
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, 87108-5138
United States
St. Louis University Health Sciences Center
St. Louis, Missouri, 63110
United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
United States
CCOP - Kansas City
Kansas City, Missouri, 64131
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-W227
United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234-6200
United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195-9001
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97207
United States
University of California Davis Cancer Center
Sacramento, California, 95817
United States
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, 39531-2410
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, 39216
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, 94553
United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565
United States
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, 29401-5799
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, 48201-1932
United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
Providence Hospital - Southfield
Southfield, Michigan, 48075-9975
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218
United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, 84148
United States
CCOP - Northwest
Tacoma, Washington, 98405-0986
United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813-2424
United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78229
United States
Madigan Army Medical Center
Tacoma, Washington, 98431-5000
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0912
United States
CCOP - Greenville
Greenville, South Carolina, 29615
United States
Veterans Affairs Medical Center - Albany
Albany, New York, 12208
United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, 45220-2288
United States
CCOP - Columbia River Program
Portland, Oregon, 97225
United States
CCOP - Beaumont
Royal Oak, Michigan, 48073-6769
United States
Additional Information:
Study ID Numbers: CDR0000069157; SWOG-S0126
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00029003
Other Bronchoalveolar Cell Lung Cancer Studies:
1. Antineoplaston Therapy in Treating Patients With Recurrent or Stage IV Lung Cancer
2. Vaccine Therapy and Sargramostim in Treating Patients With Non-small Cell Lung Cancer
3. Phase II Study of TLK286 in Patients With Advanced Non-Small Cell Lung Cancer
4. Chemotherapy and Radiation Therapy With or Without Epoetin alfa in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer
5. Karenitecin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer
Related Studies:
Other bronchoalveolar cell lung cancer Clinical Trials
Other Tennessee Clinical Trials
Other Memphis Clinical Trials
Gefitinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
|
|
|
|
|
|
|
|
