Spots Global Cancer Trial Database for S0342: Paclitaxel, Carboplatin, and Cetuximab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: S0342: Paclitaxel, Carboplatin, and Cetuximab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Official Title: Phase II Selection Design Trial Of Concurrent Chemotherapy + Cetuximab Vs. Chemotherapy Followed By Cetuximab In Advanced Non-Small Cell Lung Cancer (NSCLC)
Study ID: NCT00085501
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining more than one chemotherapy drug with a monoclonal antibody may kill more tumor cells. It is not yet known whether cetuximab is more effective when given at the same time as chemotherapy or following chemotherapy. PURPOSE: This randomized phase II trial is studying how well giving cetuximab at the same time as combination chemotherapy works compared to giving cetuximab after combination chemotherapy in treating patients with stage IIIB or stage IV non-small cell lung cancer.
Detailed Description: OBJECTIVES: Primary * Compare overall survival of patients with selected stage IIIB or stage IV non-small cell lung cancer treated with concurrent vs sequential paclitaxel, carboplatin, and cetuximab. Secondary * Compare response rates (confirmed and unconfirmed, complete and partial) in patients treated with these regimens. * Compare the toxic effects of these regimens in these patients. * Correlate epidermal growth factor receptor polymorphisms and downstream biomarkers with response to cetuximab in these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I (concurrent cetuximab): Patients receive cetuximab IV over 1 hour (over 2 hours on day 1 of course 1 only) on days 1, 8, and 15 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 8. Treatment repeats every 21 days for a total of 4 courses (12 weeks) in the absence of disease progression or unacceptable toxicity. Beginning on week 13, patients receive single-agent cetuximab IV over 1 hour once weekly in the absence of disease progression or unacceptable toxicity. * Arm II (sequential cetuximab): Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses (12 weeks) in the absence of disease progression or unacceptable toxicity. Beginning on week 13, patients receive single-agent cetuximab IV over 1 hour (over 2 hours on week 13 only) once weekly in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 180 patients (90 per treatment arm) will be accrued for this study within 9 months.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alaska Regional Hospital, Anchorage, Alaska, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Alta Bates Comprehensive Cancer Center, Berkeley, California, United States
Peninsula Medical Center, Burlingame, California, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Marin Cancer Institute at Marin General Hospital, Greenbrae, California, United States
Sutter Health Western Division Cancer Research Group, Greenbrae, California, United States
Saint Rose Hospital, Hayward, California, United States
Valley Memorial Hospital, Livermore, California, United States
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States
Highland General Hospital, Oakland, California, United States
CCOP - Bay Area Tumor Institute, Oakland, California, United States
Summit Medical Center, Oakland, California, United States
Comprehensive Cancer Center at Desert Regional Medical Center, Palm Springs, California, United States
Sutter Roseville Medical Center, Roseville, California, United States
Sutter Cancer Center, Sacramento, California, United States
University of California Davis Cancer Center, Sacramento, California, United States
Mercy General Hospital, Sacramento, California, United States
California Pacific Medical Center - California Campus, San Francisco, California, United States
J.C. Robinson, M.D. Regional Cancer Center, San Pablo, California, United States
CCOP - Santa Rosa Memorial Hospital, Sana Rosa, California, United States
St. Anthony Central Hospital, Denver, Colorado, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Denver, Colorado, United States
Veterans Affairs Medical Center - Denver, Denver, Colorado, United States
Poudre Valley Hospital, Fort Collins, Colorado, United States
Montrose Memorial Hospital Cancer Center, Montrose, Colorado, United States
St. Anthony North Hospital, Westminster, Colorado, United States
Exempla Lutheran Medical Center, Wheat Ridge, Colorado, United States
Piedmont Hospital, Atlanta, Georgia, United States
CCOP - Atlanta Regional, Atlanta, Georgia, United States
Northside Hospital Cancer Center, Atlanta, Georgia, United States
Saint Joseph's Hospital of Atlanta, Atlanta, Georgia, United States
Augusta Oncology Associates, Augusta, Georgia, United States
WellStar Cobb Hospital, Austell, Georgia, United States
Charles B. Eberhart Cancer Center at DeKalb Medical Center, Decatur, Georgia, United States
Northeast Georgia Medical Center, Gainesville, Georgia, United States
Gwinnett Medical Center, Lawrenceville, Georgia, United States
Kennestone Cancer Center at Wellstar Kennestone Hospital, Marietta, Georgia, United States
Southern Regional Medical Center, Riverdale, Georgia, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia, United States
Pearlman Comprehensive Cancer Center at South Georgia Medical Center, Valdosta, Georgia, United States
Kapiolani Medical Center at Pali Momi, Aiea, Hawaii, United States
Cancer Research Center of Hawaii, Honolula, 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
OnCare Hawaii, Incorporated - Kuakini, Honolulu, Hawaii, United States
St. Francis Medical Center, Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States
St. Luke's Mountain States Tumor Institute - Boise, Boise, Idaho, United States
Saint Anthony's Hospital at Saint Anthony's Health Center, Alton, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, United States
Hematology Oncology Consultants Ltd., Naperville, Illinois, United States
Edward Hospital Cancer Center, Naperville, Illinois, United States
St. Francis Hospital and Health Centers, Beech Grove, Indiana, United States
Genesis Regional Cancer Center at Genesis Medical Center, Davenport, Iowa, United States
Genesis Medical Center - West Campus, Davenport, Iowa, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, United States
Salina Regional Health Center, Salina, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas, United States
Tulane Cancer Center, New Orleans, Louisiana, United States
Cancer Treatment Center at Christus Schumpert St. Mary Place, Shreveport, Louisiana, United States
Cancer Research Center at Boston Medical Center, Boston, Massachusetts, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital, Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Cancer Care Center at Battle Creek Health System, Battle Creek, Michigan, United States
Bay Regional Medical Center, Bay City, Michigan, United States
Mecosta County General Hospital, Big Rapids, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Health System, Detroit, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
CCOP - Grand Rapids, Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Mercy Medical Center, Grand Rapids, Michigan, United States
Spectrum Health Cancer Care - Butterworth Campus, Grand Rapids, Michigan, United States
Metropolitan Hospital, Grand Rapids, Michigan, United States
Spectrum Health Hospital - Blodgett Campus, Grand Rapids, Michigan, United States
Holland Community Hospital, Holland, Michigan, United States
Mount Clemens General Hospital, Mount Clemens, Michigan, United States
Hackley Hospital, Muskegon, Michigan, United States
Northern Michigan Hospital, Petoskey, Michigan, United States
St. Joseph Mercy Hospital, Pontiac, Michigan, United States
Seton Cancer Institute - Saginaw, Saginaw, Michigan, United States
Munson Medical Center, Traverse City, Michigan, United States
St. John Macomb Hospital, Warren, Michigan, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Keesler Medical Center - Keesler Air Force Base, Kessler AFB, Mississippi, United States
St. Francis Medical Center, Cape Girardeau, Missouri, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital, Gape Girardeau, Missouri, United States
Freeman Cancer Institute at Freeman Health System, Joplin, 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 - St. Louis-Cape Girardeau, St. Louis, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy, St. Louis, Missouri, United States
CCOP - Montana Cancer Consortium, Billings, Montana, United States
Big Sky Oncology, Great Falls, Montana, United States
Great Falls Clinic, Great Falls, Montana, United States
Sletten Regional Cancer Institute, Great Falls, Montana, United States
Valley Hospital - Ridgewood, Ridgewood, New Jersey, United States
Adirondack Cancer Care, Glens Falls, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States
Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina, United States
Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina, United States
Pardee Memorial Hospital, Hendersonville, North Carolina, United States
Rutherford Hospital, Rutherfordton, North Carolina, United States
McDowell Cancer Center at Akron General Medical Center, Akron, Ohio, United States
Tri-Health Good Samaritan Hospital, Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Grandview Hospital, Dayton, Ohio, United States
Good Samaritan Hospital, Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley 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
Community Oncology Group - Independence, Independence, Ohio, United States
Charles F. Kettering Memorial Hospital, Kettering, Ohio, United States
MedCentral - Mansfield Hospital, Mansfield, Ohio, United States
Middletown Regional Hospital, Middletown, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center, Troy, Ohio, United States
Cleveland Clinic - Wooster, Wooster, Ohio, United States
United States Air Force Medical Center Wright-Patterson, Wright-Patterson Afb, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia, Ohio, United States
St. Charles Medical Center, Bend, Oregon, United States
Legacy Mount Hood Medical Center, Glesham, Oregon, United States
Providence Milwaukie Hospital, Milwaukie, Oregon, United States
Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center, Portland, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center, Portland, Oregon, United States
CCOP - Columbia River Oncology Program, Portland, Oregon, United States
Providence St. Vincent Medical Center, Portland, Oregon, United States
Institute of Oncology at Vilnius University, Portland, Oregon, United States
Salem Hospital Regional Cancer Center, Salem, Oregon, United States
Legacy Meridian Park Hospital, Tualatin, Oregon, United States
Rose Ramer Cancer Clinic at Anderson Area Medical Center, Anderson, South Carolina, United States
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, United States
McLeod Regional Medical Center, Florence, South Carolina, United States
Bon Secours St. Francis Health System, Greenville, South Carolina, United States
Greenville Hospital System Cancer Center, Greenville, South Carolina, United States
CCOP - Greenville, Greenville, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
Thompson Cancer Survival Center, Knoxville, Tennessee, United States
Arlington Cancer Center - Arlington, Arlington, Texas, United States
Brooke Army Medical Center, Fort Sam Houston, Texas, United States
Wilford Hall Medical Center, Lackland AFB, Texas, United States
UMC Southwest Cancer and Research Center, Lubbock, Texas, United States
Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, United States
Danville Regional Medical Center, Danville, Virginia, United States
Memorial Hospital of Martinsville and Henry County, Martinsville, Virginia, United States
St. Joseph Hospital Community Cancer Center, Bellingham, Washington, United States
Olympic Hematology and Oncology, Bremerton, Washington, United States
Cancer Care Center at Skagit Valley Hospital, Mt. Vernon, Washington, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Group Health Central Hospital, Seattle, Washington, United States
Harborview Medical Center, Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus, 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
Providence Cancer Center at Sacred Heart Medical Center, Spokane, Washington, United States
Providence Cancer Center at Holy Family Hospital, Spokane, Washington, United States
Southwest Washington Medical Center Cancer Center, Vancouver, Washington, United States
Central Washington Hospital, Wenatchee, Washington, United States
Wenatchee Valley Clinic, Wenatchee, Washington, United States
North Star Lodge Cancer Center, Yakima, Washington, United States
Washington Hematology - Oncology Specialists, Yakima, Washington, United States
Contact Details
Name: Roy S. Herbst, MD, PhD
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Karen Kelly, MD
Affiliation: University of Colorado, Denver
Role: PRINCIPAL_INVESTIGATOR
Name: David R. Gandara, MD
Affiliation: University of California, Davis
Role: PRINCIPAL_INVESTIGATOR
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