Spots Global Cancer Trial Database for S0526: Pemetrexed Disodium in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: S0526: Pemetrexed Disodium in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Official Title: Phase II Trial of Pemetrexed in Patients With Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)
Study ID: NCT00265785
Conditions
Interventions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with stage III or stage IV non-small cell lung cancer.
Detailed Description: OBJECTIVES: Primary * Assess overall survival of patients with selected stage IIIB or IV bronchoalveolar carcinoma treated with pemetrexed disodium. Secondary * Evaluate the progression-free survival of patients treated with this drug. * Evaluate the response rate (confirmed and unconfirmed, partial and complete) in the subset of patients with measurable disease treated with this drug using standard RECIST criteria and computer assisted image analysis. * Evaluate frequency and severity of toxicities in patients treated with this drug. * Perform molecular correlative studies on patient tissue to investigate potential predictors of efficacy. (This will not be completed as this study was closed due to poor accrual.) OUTLINE: Patients are stratified according to prior treatment with gefitinib or erlotinib (yes vs no). Patients receive pemetrexed disodium intravenous (IV) on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for 3 years. PROJECTED ACCRUAL: A total of 99 patients will be accrued for this study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alaska Regional Hospital Cancer Center, Anchorage, Alaska, United States
NEA Medical Center - Stadium Boulevard, Jonesboro, Arkansas, United States
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States
University of California Davis Cancer Center, Sacramento, California, United States
University of Colorado Cancer Center at UC Health Sciences Center, Aurora, Colorado, United States
Denver Health Medical Center, Denver, Colorado, United States
Kapiolani Medical Center at Pali Momi, Aiea, Hawaii, United States
Cancer Research Center of Hawaii, Honolulu, Hawaii, United States
OnCare Hawaii, Incorporated - Lusitana, Honolulu, Hawaii, United States
Queen's Cancer Institute at Queen's Medical Center, Honolulu, Hawaii, United States
Straub Clinic and Hospital, Incorporated, Honolulu, Hawaii, United States
Hawaii Medical Center - East, Honolulu, Hawaii, United States
OnCare Hawaii, Incorporated - Kuakini, Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States
Maui Memorial Medical Center, Wailuku, Hawaii, United States
St. Francis Hospital and Health Centers - Beech Grove Campus, Beech Grove, Indiana, United States
Reid Hospital & Health Care Services, Richmond, Indiana, United States
Tammy Walker Cancer Center at Salina Regional Health Center, Salina, Kansas, United States
Cotton-O'Neil Cancer Center, Topeka, Kansas, United States
Saint Joseph Mercy Cancer Center, Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States
Foote Memorial Hospital, Jackson, Michigan, United States
Sparrow Regional Cancer Center, Lansing, Michigan, United States
St. Mary Mercy Hospital, Livonia, Michigan, United States
St. Joseph Mercy Oakland, Pontiac, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital, Port Huron, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw, Saginaw, Michigan, United States
Providence Cancer Institute at Providence Hospital - Southfield Campus, Southfield, Michigan, United States
St. John Macomb Hospital, Warren, Michigan, United States
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States
St. John's Regional Health Center, Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South, Springfield, Missouri, United States
CCOP - Montana Cancer Consortium, Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings, Billings, Montana, United States
Northern Rockies Radiation Oncology Center, Billings, Montana, United States
St. Vincent Healthcare Cancer Care Services, Billings, Montana, United States
Billings Clinic - Downtown, Billings, Montana, United States
Bozeman Deaconess Cancer Center, Bozeman, Montana, United States
St. James Healthcare Cancer Care, Butte, Montana, United States
Great Falls Clinic - Main Facility, Great Falls, Montana, United States
Northern Montana Hospital, Havre, Montana, United States
St. Peter's Hospital, Helena, Montana, United States
Glacier Oncology, PLLC, Kalispell, Montana, United States
Kalispell Medical Oncology at KRMC, Kalispell, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Community Medical Center, Missoula, Montana, United States
Guardian Oncology and Center for Wellness, Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center, Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana, United States
Interlakes Oncology/Hematology PC, Rochester, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States
Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina, United States
Rutherford Hospital, Rutherfordton, North Carolina, United States
Mary Rutan Hospital, Bellefontaine, Ohio, United States
Adena Regional Medical Center, Chillicothe, Ohio, United States
Riverside Methodist Hospital Cancer Care, Columbus, Ohio, United States
CCOP - Columbus, Columbus, Ohio, United States
Grant Medical Center Cancer Care, Columbus, Ohio, United States
Mount Carmel Health - West Hospital, Columbus, Ohio, United States
Doctors Hospital at Ohio Health, Columbus, Ohio, United States
Grandview Hospital, Dayton, Ohio, United States
Good Samaritan Hospital, Dayton, Ohio, United States
Samaritan North Cancer Care Center, Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton, Dayton, Ohio, United States
CCOP - Dayton, Dayton, Ohio, United States
Grady Memorial Hospital, Delaware, Ohio, United States
Blanchard Valley Medical Associates, Findlay, Ohio, United States
Middletown Regional Hospital, Franklin, Ohio, United States
Charles F. Kettering Memorial Hospital, Kettering, Ohio, United States
Fairfield Medical Center, Lancaster, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital, Marietta, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital, Newark, Ohio, United States
Mercy Medical Center, Springfield, Ohio, United States
Community Hospital of Springfield and Clark County, Springfield, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center, Troy, Ohio, United States
Mount Carmel St. Ann's Cancer Center, Westerville, Ohio, United States
Clinton Memorial Hospital, Wilmington, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia, Ohio, United States
Genesis - Good Samaritan Hospital, Zanesville, Ohio, United States
Legacy Mount Hood Medical Center, Gresham, Oregon, United States
Providence Milwaukie Hospital, Milwaukie, Oregon, United States
Legacy Good Samaritan Hospital & Comprehensive Cancer Center, Portland, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center, Portland, Oregon, United States
Adventist Medical Center, Portland, Oregon, United States
CCOP - Columbia River Oncology Program, Portland, Oregon, United States
Providence St. Vincent Medical Center, Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center and Children's Hospital, Portland, Oregon, United States
Oregon Health and Science University Cancer Institute, Portland, Oregon, United States
Legacy Meridian Park Hospital, Tualatin, Oregon, United States
AnMed Cancer Center, Anderson, South Carolina, United States
Roper St. Francis Cancer Center at Roper Hospital, Charleston, South Carolina, United States
CCOP - Greenville, Greenville, South Carolina, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States
Danville Regional Medical Center, Danville, Virginia, United States
St. Joseph Cancer Center, Bellingham, Washington, United States
Olympic Hematology and Oncology, Bremerton, Washington, United States
Columbia Basin Hematology, Kennewick, Washington, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Harborview Medical Center, Seattle, Washington, United States
Minor and James Medical, PLLC, Seattle, Washington, United States
Group Health Central Hospital, Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus, Seattle, Washington, United States
Polyclinic First Hill, Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center, Seattle, Washington, United States
Cancer Care Northwest - Spokane South, Spokane, Washington, United States
Southwest Washington Medical Center Cancer Center, Vancouver, Washington, United States
Welch Cancer Center at Sheridan Memorial Hospital, Sheridan, Wyoming, United States
Contact Details
Name: Derick H. Lau, MD
Affiliation: University of California, Davis
Role: PRINCIPAL_INVESTIGATOR
Name: Rachel E. Sanborn, MD
Affiliation: OHSU Knight Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
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