S0342: Paclitaxel, Carboplatin, and Cetuximab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
30 oktober 2012 uppdaterad av: Southwest Oncology Group
Phase II Selection Design Trial Of Concurrent Chemotherapy + Cetuximab Vs. Chemotherapy Followed By Cetuximab In Advanced Non-Small Cell Lung Cancer (NSCLC)
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
242
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Alaska
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Anchorage, Alaska, Förenta staterna, 99508
- Alaska Regional Hospital
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Arkansas
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Little Rock, Arkansas, Förenta staterna, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Berkeley, California, Förenta staterna, 94705
- Alta Bates Comprehensive Cancer Center
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Burlingame, California, Förenta staterna, 94010
- Peninsula Medical Center
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Duarte, California, Förenta staterna, 91010
- City of Hope Comprehensive Cancer Center
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Greenbrae, California, Förenta staterna, 94904
- Sutter Health Western Division Cancer Research Group
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Greenbrae, California, Förenta staterna, 94904
- Marin Cancer Institute at Marin General Hospital
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Hayward, California, Förenta staterna, 94545
- Saint Rose Hospital
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Livermore, California, Förenta staterna, 94550
- Valley Memorial Hospital
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Los Angeles, California, Förenta staterna, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Oakland, California, Förenta staterna, 94602
- Highland General Hospital
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Oakland, California, Förenta staterna, 94609
- CCOP - Bay Area Tumor Institute
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Oakland, California, Förenta staterna, 94609
- Summit Medical Center
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Palm Springs, California, Förenta staterna, 92262
- Comprehensive Cancer Center at Desert Regional Medical Center
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Roseville, California, Förenta staterna, 95661
- Sutter Roseville Medical Center
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Sacramento, California, Förenta staterna, 95816
- Sutter Cancer Center
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Sacramento, California, Förenta staterna, 95819
- Mercy General Hospital
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Sacramento, California, Förenta staterna, 95817
- University of California Davis Cancer Center
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San Francisco, California, Förenta staterna, 94118
- California Pacific Medical Center - California Campus
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San Pablo, California, Förenta staterna, 94806
- J.C. Robinson, M.D. Regional Cancer Center
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Sana Rosa, California, Förenta staterna, 95405
- CCOP - Santa Rosa Memorial Hospital
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Colorado
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Denver, Colorado, Förenta staterna, 80220
- Veterans Affairs Medical Center - Denver
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Denver, Colorado, Förenta staterna, 80204
- St. Anthony Central Hospital
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Denver, Colorado, Förenta staterna, 80217-3364
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
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Fort Collins, Colorado, Förenta staterna, 80524
- Poudre Valley Hospital
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Montrose, Colorado, Förenta staterna, 81401
- Montrose Memorial Hospital Cancer Center
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Westminster, Colorado, Förenta staterna, 80030
- St. Anthony North Hospital
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Wheat Ridge, Colorado, Förenta staterna, 80033
- Exempla Lutheran Medical Center
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Georgia
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Atlanta, Georgia, Förenta staterna, 30309
- Piedmont Hospital
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Atlanta, Georgia, Förenta staterna, 30342
- Saint Joseph's Hospital of Atlanta
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Atlanta, Georgia, Förenta staterna, 30342
- CCOP - Atlanta Regional
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Atlanta, Georgia, Förenta staterna, 30342
- Northside Hospital Cancer Center
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Augusta, Georgia, Förenta staterna, 30901
- Augusta Oncology Associates
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Austell, Georgia, Förenta staterna, 30106
- WellStar Cobb Hospital
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Decatur, Georgia, Förenta staterna, 30033
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
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Gainesville, Georgia, Förenta staterna, 30501
- Northeast Georgia Medical Center
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Lawrenceville, Georgia, Förenta staterna, 30045
- Gwinnett Medical Center
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Marietta, Georgia, Förenta staterna, 30060
- Kennestone Cancer Center at Wellstar Kennestone Hospital
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Riverdale, Georgia, Förenta staterna, 30274
- Southern Regional Medical Center
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Savannah, Georgia, Förenta staterna, 31403
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
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Valdosta, Georgia, Förenta staterna, 31603
- Pearlman Comprehensive Cancer Center at South Georgia Medical Center
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Hawaii
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Aiea, Hawaii, Förenta staterna, 96701
- Kapiolani Medical Center at Pali Momi
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Honolula, Hawaii, Förenta staterna, 96813
- Cancer Research Center of Hawaii
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Honolulu, Hawaii, Förenta staterna, 96826
- Kapiolani Medical Center for Women and Children
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Honolulu, Hawaii, Förenta staterna, 96813
- OnCare Hawaii, Incorporated - Lusitana
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Honolulu, Hawaii, Förenta staterna, 96813
- Queen's Cancer Institute at Queen's Medical Center
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Honolulu, Hawaii, Förenta staterna, 96813
- Straub Clinic and Hospital, Incorporated
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Honolulu, Hawaii, Förenta staterna, 96817
- OnCare Hawaii, Incorporated - Kuakini
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Honolulu, Hawaii, Förenta staterna, 96817
- St. Francis Medical Center
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Idaho
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Boise, Idaho, Förenta staterna, 83712
- St. Luke's Mountain States Tumor Institute - Boise
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Illinois
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Alton, Illinois, Förenta staterna, 62002
- Saint Anthony's Hospital at Saint Anthony's Health Center
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Maywood, Illinois, Förenta staterna, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Naperville, Illinois, Förenta staterna, 60540
- Hematology Oncology Consultants Ltd.
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Naperville, Illinois, Förenta staterna, 60566
- Edward Hospital Cancer Center
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Indiana
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Beech Grove, Indiana, Förenta staterna, 46107
- St. Francis Hospital and Health Centers
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Iowa
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Davenport, Iowa, Förenta staterna, 52804
- Genesis Medical Center - West Campus
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Davenport, Iowa, Förenta staterna, 52803
- Genesis Regional Cancer Center at Genesis Medical Center
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Kansas
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Kansas City, Kansas, Förenta staterna, 66160
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
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Salina, Kansas, Förenta staterna, 67401
- Salina Regional Health Center
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Wichita, Kansas, Förenta staterna, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Louisiana
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New Orleans, Louisiana, Förenta staterna, 70112
- Tulane Cancer Center
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Shreveport, Louisiana, Förenta staterna, 71101
- Cancer Treatment Center at Christus Schumpert St. Mary Place
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02118
- Cancer Research Center at Boston Medical Center
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Michigan
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Ann Arbor, Michigan, Förenta staterna, 48109
- University Of Michigan Comprehensive Cancer Center
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Ann Arbor, Michigan, Förenta staterna, 48106-0995
- St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
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Ann Arbor, Michigan, Förenta staterna, 48100
- CCOP - Michigan Cancer Research Consortium
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Battle Creek, Michigan, Förenta staterna, 49017
- Cancer Care Center at Battle Creek Health System
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Bay City, Michigan, Förenta staterna, 48708
- Bay Regional Medical Center
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Big Rapids, Michigan, Förenta staterna, 49307
- Mecosta County General Hospital
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Detroit, Michigan, Förenta staterna, 48202
- Josephine Ford Cancer Center at Henry Ford Health System
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Flint, Michigan, Förenta staterna, 48532
- Genesys Hurley Cancer Institute
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Grand Rapids, Michigan, Förenta staterna, 49503
- CCOP - Grand Rapids
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Grand Rapids, Michigan, Förenta staterna, 49503
- Lacks Cancer Center at Saint Mary's Mercy Medical Center
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Grand Rapids, Michigan, Förenta staterna, 49503
- Spectrum Health Cancer Care - Butterworth Campus
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Grand Rapids, Michigan, Förenta staterna, 49506
- Metropolitan Hospital
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Grand Rapids, Michigan, Förenta staterna, 49506
- Spectrum Health Hospital - Blodgett Campus
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Holland, Michigan, Förenta staterna, 49423
- Holland Community Hospital
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Mount Clemens, Michigan, Förenta staterna, 48043
- Mount Clemens General Hospital
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Muskegon, Michigan, Förenta staterna, 49443
- Hackley Hospital
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Petoskey, Michigan, Förenta staterna, 49770
- Northern Michigan Hospital
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Pontiac, Michigan, Förenta staterna, 48341-2985
- St. Joseph Mercy Hospital
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Saginaw, Michigan, Förenta staterna, 48601
- Seton Cancer Institute - Saginaw
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Traverse City, Michigan, Förenta staterna, 49684
- Munson Medical Center
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Warren, Michigan, Förenta staterna, 48903
- St. John Macomb Hospital
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Mississippi
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Jackson, Mississippi, Förenta staterna, 39216
- University of Mississippi Medical Center
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Kessler AFB, Mississippi, Förenta staterna, 39534-2519
- Keesler Medical Center - Keesler Air Force Base
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Missouri
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Cape Girardeau, Missouri, Förenta staterna, 63701
- St. Francis Medical Center
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Gape Girardeau, Missouri, Förenta staterna, 63701
- Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
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Joplin, Missouri, Förenta staterna, 64804
- Freeman Cancer Institute at Freeman Health System
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Springfield, Missouri, Förenta staterna, 65804
- St. John's Regional Health Center
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Springfield, Missouri, Förenta staterna, 65807
- Hulston Cancer Center at Cox Medical Center South
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St. Louis, Missouri, Förenta staterna, 63141
- CCOP - St. Louis-Cape Girardeau
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St. Louis, Missouri, Förenta staterna, 63141
- David C. Pratt Cancer Center at St. John's Mercy
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Montana
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Billings, Montana, Förenta staterna, 59101
- CCOP - Montana Cancer Consortium
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Great Falls, Montana, Förenta staterna, 59405
- Great Falls Clinic
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Great Falls, Montana, Förenta staterna, 59405
- Big Sky Oncology
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Great Falls, Montana, Förenta staterna, 59405
- Sletten Regional Cancer Institute
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New Jersey
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Ridgewood, New Jersey, Förenta staterna, 07450
- Valley Hospital - Ridgewood
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New York
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Glens Falls, New York, Förenta staterna, 12801
- Adirondack Cancer Care
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Rochester, New York, Förenta staterna, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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North Carolina
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Charlotte, North Carolina, Förenta staterna, 28203
- Blumenthal Cancer Center at Carolinas Medical Center
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Goldsboro, North Carolina, Förenta staterna, 27534
- Wayne Memorial Hospital, Incorporated
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Hendersonville, North Carolina, Förenta staterna, 28791
- Pardee Memorial Hospital
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Rutherfordton, North Carolina, Förenta staterna, 28139
- Rutherford Hospital
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Ohio
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Akron, Ohio, Förenta staterna, 44307
- McDowell Cancer Center at Akron General Medical Center
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Cincinnati, Ohio, Förenta staterna, 45220
- Tri-Health Good Samaritan Hospital
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Cleveland, Ohio, Förenta staterna, 44195
- Cleveland Clinic Taussig Cancer Center
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Dayton, Ohio, Förenta staterna, 45428
- Veterans Affairs Medical Center - Dayton
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Dayton, Ohio, Förenta staterna, 45405
- Grandview Hospital
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Dayton, Ohio, Förenta staterna, 45406
- Good Samaritan Hospital
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Dayton, Ohio, Förenta staterna, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
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Dayton, Ohio, Förenta staterna, 45415
- Samaritan North Cancer Care Center
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Dayton, Ohio, Förenta staterna, 45429
- CCOP - Dayton
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Independence, Ohio, Förenta staterna, 44131
- Community Oncology Group - Independence
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Kettering, Ohio, Förenta staterna, 45429
- Charles F. Kettering Memorial Hospital
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Mansfield, Ohio, Förenta staterna, 44903
- MedCentral - Mansfield Hospital
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Middletown, Ohio, Förenta staterna, 45044
- Middletown Regional Hospital
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Troy, Ohio, Förenta staterna, 45373
- UVMC Cancer Care Center at Upper Valley Medical Center
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Wooster, Ohio, Förenta staterna, 44691
- Cleveland Clinic - Wooster
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Wright-Patterson Afb, Ohio, Förenta staterna, 45433-5529
- United States Air Force Medical Center Wright-Patterson
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Xenia, Ohio, Förenta staterna, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
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Oregon
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Bend, Oregon, Förenta staterna, 97701
- St. Charles Medical Center
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Glesham, Oregon, Förenta staterna, 97030
- Legacy Mount Hood Medical Center
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Milwaukie, Oregon, Förenta staterna, 97222
- Providence Milwaukie Hospital
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Portland, Oregon, Förenta staterna, 97225
- CCOP - Columbia River Oncology Program
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Portland, Oregon, Förenta staterna, 97225
- Providence St. Vincent Medical Center
-
Portland, Oregon, Förenta staterna, 97210
- Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center
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Portland, Oregon, Förenta staterna, 97213
- Providence Cancer Center at Providence Portland Medical Center
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Portland, Oregon, Förenta staterna, 97227
- Institute of Oncology at Vilnius University
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Salem, Oregon, Förenta staterna, 97309
- Salem Hospital Regional Cancer Center
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Tualatin, Oregon, Förenta staterna, 97062
- Legacy Meridian Park Hospital
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South Carolina
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Anderson, South Carolina, Förenta staterna, 29621
- Rose Ramer Cancer Clinic at Anderson Area Medical Center
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Charleston, South Carolina, Förenta staterna, 29425
- Hollings Cancer Center at Medical University of South Carolina
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Florence, South Carolina, Förenta staterna, 29506
- McLeod Regional Medical Center
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Greenville, South Carolina, Förenta staterna, 29615
- CCOP - Greenville
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Greenville, South Carolina, Förenta staterna, 29601
- Bon Secours St. Francis Health System
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Greenville, South Carolina, Förenta staterna, 29605
- Greenville Hospital System Cancer Center
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Spartanburg, South Carolina, Förenta staterna, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
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Spartanburg, South Carolina, Förenta staterna, 29304
- CCOP - Upstate Carolina
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Tennessee
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Knoxville, Tennessee, Förenta staterna, 37916
- Thompson Cancer Survival Center
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Texas
-
Arlington, Texas, Förenta staterna, 76012
- Arlington Cancer Center - Arlington
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Fort Sam Houston, Texas, Förenta staterna, 78234
- Brooke Army Medical Center
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Lackland AFB, Texas, Förenta staterna, 78236
- Wilford Hall Medical Center
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Lubbock, Texas, Förenta staterna, 79415
- UMC Southwest Cancer and Research Center
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Utah
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Salt Lake City, Utah, Förenta staterna, 84112
- Huntsman Cancer Institute at University of Utah
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Virginia
-
Danville, Virginia, Förenta staterna, 24541
- Danville Regional Medical Center
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Martinsville, Virginia, Förenta staterna, 24115
- Memorial Hospital of Martinsville and Henry County
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Washington
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Bellingham, Washington, Förenta staterna, 98225
- St. Joseph Hospital Community Cancer Center
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Bremerton, Washington, Förenta staterna, 98310
- Olympic Hematology and Oncology
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Mt. Vernon, Washington, Förenta staterna, 98273
- Cancer Care Center at Skagit Valley Hospital
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Seattle, Washington, Förenta staterna, 98104
- Harborview Medical Center
-
Seattle, Washington, Förenta staterna, 98104
- Fred Hutchinson Cancer Research Center
-
Seattle, Washington, Förenta staterna, 98195
- University Cancer Center at University of Washington Medical Center
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Seattle, Washington, Förenta staterna, 98104
- Group Health Central Hospital
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Seattle, Washington, Förenta staterna, 98114
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
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Spokane, Washington, Förenta staterna, 99202
- Cancer Care Northwest - Spokane South
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Spokane, Washington, Förenta staterna, 99204
- Providence Cancer Center at Sacred Heart Medical Center
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Spokane, Washington, Förenta staterna, 99207
- Providence Cancer Center at Holy Family Hospital
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Vancouver, Washington, Förenta staterna, 98668
- Southwest Washington Medical Center Cancer Center
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Wenatchee, Washington, Förenta staterna, 98801
- Central Washington Hospital
-
Wenatchee, Washington, Förenta staterna, 98801
- Wenatchee Valley Clinic
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Yakima, Washington, Förenta staterna, 98902
- North Star Lodge Cancer Center
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Yakima, Washington, Förenta staterna, 98902
- Washington Hematology - Oncology Specialists
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of one of the following stages:
- Newly diagnosed selected stage IIIB disease (T4 lesion due to malignant pleural effusion, any N, M0)
- Newly diagnosed stage IV disease (any T, any N, M1)
- Recurrent stage IV disease after prior surgery or radiotherapy
The following subtypes are eligible:
- Adenocarcinoma
- Squamous cell carcinoma
- Large cell carcinoma
- Unspecified
Measurable disease by CT scan, MRI, x-ray, or physical exam
- Pleural effusions, ascites, or laboratory parameters are not acceptable as the only evidence of disease
- Not within prior radiotherapy field unless a new lesion is present
- Not within area of prior surgical resection
- No known brain metastases by CT scan or MRI
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9 mg/dL
Hepatic
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- SGOT or SGPT ≤ 2 times ULN
- Alkaline phosphatase ≤ 2 times ULN
- No known acute hepatitis
Renal
- Creatinine ≤ ULN
- Creatinine clearance ≥ 50 mL/min
Cardiovascular
- No significant cardiac disease
- No uncontrolled hypertension
- No unstable angina
- No congestive heart failure
Other
- 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 active or uncontrolled infection
- No sensory neuropathy ≥ grade 2
- No known human anti-mouse antibodies
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior biologic therapy for NSCLC
- No prior chimeric or murine monoclonal antibody therapy
- No prior cetuximab
Chemotherapy
- No prior systemic chemotherapy for NSCLC
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy and recovered
Surgery
- See Disease Characteristics
- At least 2 weeks since prior thoracic or major surgery and recovered
Other
- No prior gefitinib or other investigational agents that target the epidermal growth factor receptor pathway
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 2
|
Arm 1: 400 mg/m2 (Initial dose), 2 hour IV infusion on Day 1, Week 1 only. 250 mg/m2 (Subsequent doses), 1 hour IV infusion, on Day 1 weekly starting at Week 2. Arm 2: 400 mg/m2 (Initial dose), 2 hour IV infusion on Week 13 ONLY 250 mg/m2 (Subsequent doses), 1 hour IV infusion, weekly starting at Week 14. Arm 1: AUC=6 30 minute IV infusion immediately following paclitaxel on Day 1 q 21 days x 4 starting at Week 2 Arm 2: AUC=6 30 minute IV infusion immediately following paclitaxel on Day 1 q 21 days x 4 starting at Week 1 Arm 1: 225 mg/m2 3 hour IV infusion 1 hour following cetuximab on Day 1, q 21 days x 4 Starting at Week 4. Arm 2: 225 mg/m2 3 hour IV infusion 1 hour following cetuximab on Day 1, q 21 days x 4 Starting at Week 1. |
|
Aktiv komparator: 1
|
Arm 1: 400 mg/m2 (Initial dose), 2 hour IV infusion on Day 1, Week 1 only. 250 mg/m2 (Subsequent doses), 1 hour IV infusion, on Day 1 weekly starting at Week 2. Arm 2: 400 mg/m2 (Initial dose), 2 hour IV infusion on Week 13 ONLY 250 mg/m2 (Subsequent doses), 1 hour IV infusion, weekly starting at Week 14. Arm 1: AUC=6 30 minute IV infusion immediately following paclitaxel on Day 1 q 21 days x 4 starting at Week 2 Arm 2: AUC=6 30 minute IV infusion immediately following paclitaxel on Day 1 q 21 days x 4 starting at Week 1 Arm 1: 225 mg/m2 3 hour IV infusion 1 hour following cetuximab on Day 1, q 21 days x 4 Starting at Week 4. Arm 2: 225 mg/m2 3 hour IV infusion 1 hour following cetuximab on Day 1, q 21 days x 4 Starting at Week 1. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Select a regimen based on overall survival
Tidsram: From date of registration until the date of progression or date of death from any cause, whichever came first, assessed up to 3 years
|
To select a regimen based on overall survival via a Phase II selection design of chemotherapy in conjunction with cetuximab (concurrent vs. sequential) for Phase III testing against chemotherapy alone in Stage IIIB and Stage IV non-small cell lung cancer.
|
From date of registration until the date of progression or date of death from any cause, whichever came first, assessed up to 3 years
|
|
Response rate (confirmed and unconfirmed, complete and partial response)
Tidsram: From date of registration until the date of progression or date of death from any cause, whichever came first, assessed up to 3 years
|
To evaluate response rates (confirmed and unconfirmed, complete and partial) of patients with selected Stage IIIB and Stage IV NSCLC treated with paclitaxel and carboplatin with concurrent cetuximab or paclitaxel and carboplatin followed by cetuximab.
|
From date of registration until the date of progression or date of death from any cause, whichever came first, assessed up to 3 years
|
|
Toxicities
Tidsram: From date of registration until the date of progression or date of death from any cause, whichever came first, assessed up to 3 years
|
To evaluate the toxicities of the two treatment regimens in patients with selected Stage IIIB and Stage IV NSCLC.
|
From date of registration until the date of progression or date of death from any cause, whichever came first, assessed up to 3 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Correlation of epidermal growth factor receptor polymorphisms and downstream biomarkers with response
Tidsram: At prestudy
|
To conduct exploratory molecular correlative studies of the EGFR-HER signaling pathways examining activated phosphoproteins, oncogenic mutations and rates of proliferation and apoptosis in patient tissues (see S9925 for details).
|
At prestudy
|
|
Evaluate EGFR polymorphisms
Tidsram: At prestudy and week 5
|
To evaluate EGFR polymorphisms as a potential correlate for response to cetuximab (see S9925 for details).
|
At prestudy and week 5
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Karen Kelly, MD, University of Colorado, Denver
- Huvudutredare: Roy S. Herbst, MD, PhD, M.D. Anderson Cancer Center
- Huvudutredare: David R. Gandara, MD, University of California, Davis
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Franklin WA, Gandara DR, Kim ES, et al.: SWOG S0342 and S0536: expression of EGFR protein and markers of epithelial-mesenchymal transformation (EMT) in cetuximab/chemotherapy-treated non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 27 (Suppl 15): A-11076, 2009.
- Mack PC, Holland WS, Redman M, et al.: KRAS mutation analysis in cetuximab-treated advanced stage non-small cell lung cancer (NSCLC): SWOG experience with S0342 and S0536. [Abstract] J Clin Oncol 27 (Suppl15): A-8022, 2009.
- Hirsch FR, Herbst RS, Olsen C, Chansky K, Crowley J, Kelly K, Franklin WA, Bunn PA Jr, Varella-Garcia M, Gandara DR. Increased EGFR gene copy number detected by fluorescent in situ hybridization predicts outcome in non-small-cell lung cancer patients treated with cetuximab and chemotherapy. J Clin Oncol. 2008 Jul 10;26(20):3351-7. doi: 10.1200/JCO.2007.14.0111.
- Herbst RS, Chansky K, Kelly K, et al.: A phase II randomized selection trial evaluating concurrent chemotherapy plus cetuximab or chemotherapy followed by cetuximab in patients with advanced non-small cell lung cancer (NSCLC): final report of SWOG 0342. [Abstract] J Clin Oncol 25 (Suppl 18): A-7545, 395s, 2007.
- Kelly K, Herbst RS, Crowley JJ, et al.: Concurrent chemotherapy plus cetuximab or chemotherapy followed by cetuximab in advanced non-small cell lung cancer (NSCLC): a randomized phase II selectional trial SWOG 0342. [Abstract] J Clin Oncol 24 (Suppl 18): A-7015, 367s, 2006.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2004
Primärt slutförande (Faktisk)
1 augusti 2007
Avslutad studie (Faktisk)
1 juli 2011
Studieregistreringsdatum
Först inskickad
10 juni 2004
Först inskickad som uppfyllde QC-kriterierna
10 juni 2004
Första postat (Uppskatta)
11 juni 2004
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
1 november 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 oktober 2012
Senast verifierad
1 oktober 2012
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Luftvägssjukdomar
- Neoplasmer
- Lungsjukdomar
- Neoplasmer efter plats
- Neoplasmer i andningsvägarna
- Thoracic neoplasmer
- Karcinom, bronkogent
- Bronkiella neoplasmer
- Lungneoplasmer
- Karcinom, icke-småcellig lunga
- Molekylära mekanismer för farmakologisk verkan
- Antineoplastiska medel
- Tubulin modulatorer
- Antimitotiska medel
- Mitosmodulatorer
- Antineoplastiska medel, fytogena
- Antineoplastiska medel, immunologiska
- Karboplatin
- Paklitaxel
- Cetuximab
Andra studie-ID-nummer
- CDR0000370806
- U10CA032102 (U.S.S. NIH-anslag/kontrakt)
- S0342 (Annan identifierare: SWOG)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .