Spots Global Cancer Trial Database for S0709: Erlotinib With or Without Carboplatin and Paclitaxel in Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: S0709: Erlotinib With or Without Carboplatin and Paclitaxel in Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Official Title: A Phase II Selection Design of Pharmacodynamic Separation of Carboplatin/Paclitaxel/OSI-774 (Erlotinib; NSC-718781) or OSI-774 Alone in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients With Performance Status 2 (PS-2)
Study ID: NCT00661193
Conditions
Study Description
Brief Summary: RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving erlotinib together with carboplatin and paclitaxel may kill more tumor cells. PURPOSE: This randomized phase II trial is studying how well erlotinib works when given alone or together with carboplatin and paclitaxel in treating patients with stage IIIB or stage IV non-small cell lung cancer.
Detailed Description: OBJECTIVES: Primary * To select a regimen (erlotinib hydrochloride with or without carboplatin and paclitaxel) for further testing against standard treatment, based on median progression-free survival for ≥ 3 months, in patients with stage IIIB or IV non-small cell lung cancer with a Zubrod performance status of 2. Secondary * To assess the feasibility of selecting patients for a trial based on central EGFR testing of serum in a cooperative group setting. * To evaluate the objective tumor response rates (confirmed and unconfirmed, complete and partial response), in a subset of patients with measurable disease. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 2 years.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Kaiser Permanente - Deer Valley, Antioch, California, United States
Alta Bates Summit Comprehensive Cancer Center, Berkeley, California, United States
Peninsula Medical Center, Burlingame, California, United States
Kaiser Permanente - Fremont, Fremont, California, United States
Kaiser Permanente Medical Center - Hayward, Hayward, California, United States
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States
Contra Costa Regional Medical Center, Martinez, California, United States
Tibotec Therapeutics - Division of Ortho Biotech Products, LP, Marysville, California, United States
El Camino Hospital Cancer Center, Mountain View, California, United States
Sutter Health - Western Division Cancer Research Group, Novato, California, United States
Highland General Hospital, Oakland, California, United States
Alta Bates Summit Medical Center - Summit Campus, Oakland, California, United States
CCOP - Bay Area Tumor Institute, Oakland, California, United States
Kaiser Permanente Medical Center - Oakland, Oakland, California, United States
Epic Care - Oakland, Oakland, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange, California, United States
Kaiser Permanente Medical Center - Redwood City, Redwood City, California, United States
Kaiser Permanente Medical Center - Richmond, Richmond, California, United States
Kaiser Permanente Medical Center - Roseville, Roseville, California, United States
University of California Davis Cancer Center, Sacramento, California, United States
South Sacramento Kaiser-Permanente Medical Center, Sacramento, California, United States
Kaiser Permanente Medical Center - Sacramento, Sacramento, California, United States
Kaiser Permanente Medical Center - San Francisco Geary Campus, San Francisco, California, United States
California Pacific Medical Center - California Campus, San Francisco, California, United States
Kaiser Permanente Medical Center - Santa Teresa, San Jose, California, United States
Doctors Medical Center - San Pablo Campus, San Pablo, California, United States
Kaiser Foundation Hospital - San Rafael, San Rafael, California, United States
Kaiser Permanente Medical Center - Santa Clara Kiely Campus, Santa Clara, California, United States
Kaiser Permanente Medical Center - Santa Rosa, Santa Rosa, California, United States
Kaiser Permanente Medical Center - South San Francisco, South San Francisco, California, United States
Kaiser Permanente Medical Facility - Stockton, Stockton, California, United States
Tahoe Forest Cancer Center, Truckee, California, United States
Kaiser Permanente Medical Center - Vacaville, Vacaville, California, United States
Kaiser Permanente Medical Center - Vallejo, Vallejo, California, United States
Sutter Solano Medical Center, Vallejo, California, United States
Kaiser Permanente Medical Center - Walnut Creek, Walnut Creek, California, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center, Hartford, Connecticut, United States
Pearlman Comprehensive Cancer Center at South Georgia Medical Center, Valdosta, Georgia, United States
Kaiser Permanente - Moanalua Medical Center and Clinic, Honolulu, Hawaii, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center, Boise, Idaho, United States
Mountain States Tumor Institute at St. Luke's Regional Medical Center, Boise, Idaho, United States
Saint Luke's Mountain States Tumor Institute - Fruitland, Fruitland, Idaho, United States
Mountain States Tumor Institute - Meridian, Meridian, Idaho, United States
Saint Luke's Mountain States Tumor Institute, Nampa, Idaho, United States
Mountain States Tumor Institute at St. Luke's, Twin Falls, Idaho, United States
Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois, United States
Regional Cancer Center at Memorial Medical Center, Springfield, Illinois, United States
St. Rose Ambulatory and Surgery Center, Great Bend, Kansas, United States
Hays Medical Center, Hays, Kansas, United States
Hutchinson Hospital Corporation, Hutchinson, Kansas, United States
Kansas City Cancer Centers - West, Kansas City, Kansas, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, United States
Kansas City Cancer Centers - Southwest, Overland Park, Kansas, United States
Mount Carmel Regional Cancer Center, Pittsburg, Kansas, United States
Tammy Walker Cancer Center at Salina Regional Health Center, Salina, Kansas, United States
Kansas City Cancer Center - Shawnee Mission, Shawnee Mission, Kansas, United States
St. Francis Comprehensive Cancer Center, Topeka, Kansas, United States
Veterans Affairs Medical Center - Topeka (O'Neil), Topeka, Kansas, United States
Cancer Center of Kansas, PA - Winfield, Winfield, Kansas, United States
Lahey Clinic Medical Center - Burlington, Burlington, Massachusetts, 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
Barbara Ann Karmanos Cancer Institute, Detroit, 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
St. John Macomb Hospital, Warren, Michigan, United States
Regional Cancer Center at Singing River Hospital, Pascagoula, Mississippi, United States
Truman Medical Center - Hospital Hill, Kansas City, Missouri, United States
Veterans Affairs Medical Center - Kansas City, Kansas City, Missouri, United States
Kansas City Cancer Centers - South, Kansas City, Missouri, United States
Kansas City Cancer Centers - North, Kansas City, Missouri, United States
Kansas City Cancer Centers - East, Lee's Summit, Missouri, 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
St. Vincent Healthcare Cancer Care Services, Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings, Billings, Montana, United States
Billings Clinic - Downtown, Billings, Montana, United States
Bozeman Deaconess Cancer Center, Bozeman, Montana, United States
Great Falls Clinic - Main Facility, Great Falls, Montana, United States
Sletten Cancer Institute at Benefis Healthcare, Great Falls, Montana, United States
St. Peter's Hospital, Helena, Montana, United States
Glacier Oncology, PLLC, Kalispell, Montana, United States
Kalispell Regional Medical Center, Kalispell, 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
Randolph Hospital, Asheboro, North Carolina, United States
Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina, United States
Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina, United States
Moses Cone Regional Cancer Center at Wesley Long Community Hospital, Greensboro, North Carolina, United States
Harrington Cancer Center, Amarillo, Texas, United States
Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, United States
Danville Regional Medical Center, Danville, Virginia, United States
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County, Martinsville, Virginia, United States
Island Hospital Cancer Care Center at Island Hospital, Anacortes, Washington, United States
St. Joseph Cancer Center, Bellingham, Washington, United States
Olympic Hematology and Oncology, Bremerton, Washington, United States
Highline Medical Center Cancer Center, Burien, Washington, United States
Swedish Medical Center - Issaquah Campus, Issaquah, Washington, United States
Columbia Basin Hematology, Kennewick, Washington, United States
Skagit Valley Hospital Cancer Care Center, Mount Vernon, Washington, United States
Harrison Poulsbo Hematology and Onocology, Poulsbo, Washington, United States
Harborview Medical Center, Seattle, Washington, United States
Minor and James Medical, PLLC, Seattle, Washington, United States
Fred Hutchinson Cancer Research Center, 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
North Puget Oncology at United General Hospital, Sedro-Woolley, Washington, United States
Cancer Care Northwest - Spokane South, Spokane, Washington, United States
Evergreen Hematology and Oncology, PS, Spokane, Washington, United States
Wenatchee Valley Medical Center, Wenatchee, Washington, United States
Rocky Mountain Oncology, Casper, Wyoming, United States
Contact Details
Name: Primo N. Lara, MD
Affiliation: University of California, Davis
Role: STUDY_CHAIR
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