- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00085501
S0342: Paclitaxel, Carboplatin, and Cetuximab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Alaska
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Anchorage, Alaska, Vereinigte Staaten, 99508
- Alaska Regional Hospital
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Arkansas
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Little Rock, Arkansas, Vereinigte Staaten, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Berkeley, California, Vereinigte Staaten, 94705
- Alta Bates Comprehensive Cancer Center
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Burlingame, California, Vereinigte Staaten, 94010
- Peninsula Medical Center
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Duarte, California, Vereinigte Staaten, 91010
- City of Hope Comprehensive Cancer Center
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Greenbrae, California, Vereinigte Staaten, 94904
- Sutter Health Western Division Cancer Research Group
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Greenbrae, California, Vereinigte Staaten, 94904
- Marin Cancer Institute at Marin General Hospital
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Hayward, California, Vereinigte Staaten, 94545
- Saint Rose Hospital
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Livermore, California, Vereinigte Staaten, 94550
- Valley Memorial Hospital
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Los Angeles, California, Vereinigte Staaten, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Oakland, California, Vereinigte Staaten, 94602
- Highland General Hospital
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Oakland, California, Vereinigte Staaten, 94609
- CCOP - Bay Area Tumor Institute
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Oakland, California, Vereinigte Staaten, 94609
- Summit Medical Center
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Palm Springs, California, Vereinigte Staaten, 92262
- Comprehensive Cancer Center at Desert Regional Medical Center
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Roseville, California, Vereinigte Staaten, 95661
- Sutter Roseville Medical Center
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Sacramento, California, Vereinigte Staaten, 95816
- Sutter Cancer center
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Sacramento, California, Vereinigte Staaten, 95819
- Mercy General Hospital
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Sacramento, California, Vereinigte Staaten, 95817
- University of California Davis Cancer Center
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San Francisco, California, Vereinigte Staaten, 94118
- California Pacific Medical Center - California Campus
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San Pablo, California, Vereinigte Staaten, 94806
- J.C. Robinson, M.D. Regional Cancer Center
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Sana Rosa, California, Vereinigte Staaten, 95405
- CCOP - Santa Rosa Memorial Hospital
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Colorado
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Denver, Colorado, Vereinigte Staaten, 80220
- Veterans Affairs Medical Center - Denver
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Denver, Colorado, Vereinigte Staaten, 80204
- St. Anthony Central Hospital
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Denver, Colorado, Vereinigte Staaten, 80217-3364
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
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Fort Collins, Colorado, Vereinigte Staaten, 80524
- Poudre Valley Hospital
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Montrose, Colorado, Vereinigte Staaten, 81401
- Montrose Memorial Hospital Cancer Center
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Westminster, Colorado, Vereinigte Staaten, 80030
- St. Anthony North Hospital
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Wheat Ridge, Colorado, Vereinigte Staaten, 80033
- Exempla Lutheran Medical Center
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Georgia
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Atlanta, Georgia, Vereinigte Staaten, 30309
- Piedmont Hospital
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Atlanta, Georgia, Vereinigte Staaten, 30342
- Saint Joseph's Hospital of Atlanta
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Atlanta, Georgia, Vereinigte Staaten, 30342
- CCOP - Atlanta Regional
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Atlanta, Georgia, Vereinigte Staaten, 30342
- Northside Hospital Cancer Center
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Augusta, Georgia, Vereinigte Staaten, 30901
- Augusta Oncology Associates
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Austell, Georgia, Vereinigte Staaten, 30106
- WellStar Cobb Hospital
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Decatur, Georgia, Vereinigte Staaten, 30033
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
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Gainesville, Georgia, Vereinigte Staaten, 30501
- Northeast Georgia Medical Center
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Lawrenceville, Georgia, Vereinigte Staaten, 30045
- Gwinnett Medical Center
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Marietta, Georgia, Vereinigte Staaten, 30060
- Kennestone Cancer Center at Wellstar Kennestone Hospital
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Riverdale, Georgia, Vereinigte Staaten, 30274
- Southern Regional Medical Center
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Savannah, Georgia, Vereinigte Staaten, 31403
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
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Valdosta, Georgia, Vereinigte Staaten, 31603
- Pearlman Comprehensive Cancer Center at South Georgia Medical Center
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Hawaii
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Aiea, Hawaii, Vereinigte Staaten, 96701
- Kapiolani Medical Center at Pali Momi
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Honolula, Hawaii, Vereinigte Staaten, 96813
- Cancer Research Center of Hawaii
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Honolulu, Hawaii, Vereinigte Staaten, 96826
- Kapiolani Medical Center for Women and Children
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Honolulu, Hawaii, Vereinigte Staaten, 96813
- OnCare Hawaii, Incorporated - Lusitana
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Honolulu, Hawaii, Vereinigte Staaten, 96813
- Queen's Cancer Institute at Queen's Medical Center
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Honolulu, Hawaii, Vereinigte Staaten, 96813
- Straub Clinic and Hospital, Incorporated
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Honolulu, Hawaii, Vereinigte Staaten, 96817
- OnCare Hawaii, Incorporated - Kuakini
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Honolulu, Hawaii, Vereinigte Staaten, 96817
- St. Francis Medical Center
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Idaho
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Boise, Idaho, Vereinigte Staaten, 83712
- St. Luke's Mountain States Tumor Institute - Boise
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Illinois
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Alton, Illinois, Vereinigte Staaten, 62002
- Saint Anthony's Hospital at Saint Anthony's Health Center
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Maywood, Illinois, Vereinigte Staaten, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Naperville, Illinois, Vereinigte Staaten, 60540
- Hematology Oncology Consultants Ltd.
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Naperville, Illinois, Vereinigte Staaten, 60566
- Edward Hospital Cancer Center
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Indiana
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Beech Grove, Indiana, Vereinigte Staaten, 46107
- St. Francis Hospital and Health Centers
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-
Iowa
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Davenport, Iowa, Vereinigte Staaten, 52804
- Genesis Medical Center - West Campus
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Davenport, Iowa, Vereinigte Staaten, 52803
- Genesis Regional Cancer Center at Genesis Medical Center
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Kansas
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Kansas City, Kansas, Vereinigte Staaten, 66160
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
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Salina, Kansas, Vereinigte Staaten, 67401
- Salina Regional Health Center
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Wichita, Kansas, Vereinigte Staaten, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Louisiana
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New Orleans, Louisiana, Vereinigte Staaten, 70112
- Tulane Cancer Center
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Shreveport, Louisiana, Vereinigte Staaten, 71101
- Cancer Treatment Center at Christus Schumpert St. Mary Place
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02118
- Cancer Research Center at Boston Medical Center
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Michigan
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Ann Arbor, Michigan, Vereinigte Staaten, 48109
- University of Michigan Comprehensive Cancer Center
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Ann Arbor, Michigan, Vereinigte Staaten, 48106-0995
- St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
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Ann Arbor, Michigan, Vereinigte Staaten, 48100
- CCOP - Michigan Cancer Research Consortium
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Battle Creek, Michigan, Vereinigte Staaten, 49017
- Cancer Care Center at Battle Creek Health System
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Bay City, Michigan, Vereinigte Staaten, 48708
- Bay Regional Medical Center
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Big Rapids, Michigan, Vereinigte Staaten, 49307
- Mecosta County General Hospital
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Detroit, Michigan, Vereinigte Staaten, 48202
- Josephine Ford Cancer Center at Henry Ford Health System
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Flint, Michigan, Vereinigte Staaten, 48532
- Genesys Hurley Cancer Institute
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Grand Rapids, Michigan, Vereinigte Staaten, 49503
- CCOP - Grand Rapids
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Grand Rapids, Michigan, Vereinigte Staaten, 49503
- Lacks Cancer Center at Saint Mary's Mercy Medical Center
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Grand Rapids, Michigan, Vereinigte Staaten, 49503
- Spectrum Health Cancer Care - Butterworth Campus
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Grand Rapids, Michigan, Vereinigte Staaten, 49506
- Metropolitan Hospital
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Grand Rapids, Michigan, Vereinigte Staaten, 49506
- Spectrum Health Hospital - Blodgett Campus
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Holland, Michigan, Vereinigte Staaten, 49423
- Holland Community Hospital
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Mount Clemens, Michigan, Vereinigte Staaten, 48043
- Mount Clemens General Hospital
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Muskegon, Michigan, Vereinigte Staaten, 49443
- Hackley Hospital
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Petoskey, Michigan, Vereinigte Staaten, 49770
- Northern Michigan Hospital
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Pontiac, Michigan, Vereinigte Staaten, 48341-2985
- St. Joseph Mercy Hospital
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Saginaw, Michigan, Vereinigte Staaten, 48601
- Seton Cancer Institute - Saginaw
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Traverse City, Michigan, Vereinigte Staaten, 49684
- Munson Medical Center
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Warren, Michigan, Vereinigte Staaten, 48903
- St. John Macomb Hospital
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Mississippi
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Jackson, Mississippi, Vereinigte Staaten, 39216
- University of Mississippi Medical Center
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Kessler AFB, Mississippi, Vereinigte Staaten, 39534-2519
- Keesler Medical Center - Keesler Air Force Base
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Missouri
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Cape Girardeau, Missouri, Vereinigte Staaten, 63701
- St. Francis Medical Center
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Gape Girardeau, Missouri, Vereinigte Staaten, 63701
- Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
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Joplin, Missouri, Vereinigte Staaten, 64804
- Freeman Cancer Institute at Freeman Health System
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Springfield, Missouri, Vereinigte Staaten, 65804
- St. John's Regional Health Center
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Springfield, Missouri, Vereinigte Staaten, 65807
- Hulston Cancer Center at Cox Medical Center South
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St. Louis, Missouri, Vereinigte Staaten, 63141
- CCOP - St. Louis-Cape Girardeau
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St. Louis, Missouri, Vereinigte Staaten, 63141
- David C. Pratt Cancer Center at St. John's Mercy
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Montana
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Billings, Montana, Vereinigte Staaten, 59101
- CCOP - Montana Cancer Consortium
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Great Falls, Montana, Vereinigte Staaten, 59405
- Great Falls Clinic
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Great Falls, Montana, Vereinigte Staaten, 59405
- Big Sky Oncology
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Great Falls, Montana, Vereinigte Staaten, 59405
- Sletten Regional Cancer Institute
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New Jersey
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Ridgewood, New Jersey, Vereinigte Staaten, 07450
- Valley Hospital - Ridgewood
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-
New York
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Glens Falls, New York, Vereinigte Staaten, 12801
- Adirondack Cancer Care
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Rochester, New York, Vereinigte Staaten, 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, Vereinigte Staaten, 28203
- Blumenthal Cancer Center at Carolinas Medical Center
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Goldsboro, North Carolina, Vereinigte Staaten, 27534
- Wayne Memorial Hospital, Incorporated
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Hendersonville, North Carolina, Vereinigte Staaten, 28791
- Pardee Memorial Hospital
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Rutherfordton, North Carolina, Vereinigte Staaten, 28139
- Rutherford Hospital
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Ohio
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Akron, Ohio, Vereinigte Staaten, 44307
- McDowell Cancer Center at Akron General Medical Center
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Cincinnati, Ohio, Vereinigte Staaten, 45220
- Tri-Health Good Samaritan Hospital
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Cleveland, Ohio, Vereinigte Staaten, 44195
- Cleveland Clinic Taussig Cancer Center
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Dayton, Ohio, Vereinigte Staaten, 45428
- Veterans Affairs Medical Center - Dayton
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Dayton, Ohio, Vereinigte Staaten, 45405
- Grandview Hospital
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Dayton, Ohio, Vereinigte Staaten, 45406
- Good Samaritan Hospital
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Dayton, Ohio, Vereinigte Staaten, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
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Dayton, Ohio, Vereinigte Staaten, 45415
- Samaritan North Cancer Care Center
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Dayton, Ohio, Vereinigte Staaten, 45429
- CCOP - Dayton
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Independence, Ohio, Vereinigte Staaten, 44131
- Community Oncology Group - Independence
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Kettering, Ohio, Vereinigte Staaten, 45429
- Charles F. Kettering Memorial Hospital
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Mansfield, Ohio, Vereinigte Staaten, 44903
- MedCentral - Mansfield Hospital
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Middletown, Ohio, Vereinigte Staaten, 45044
- Middletown Regional Hospital
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Troy, Ohio, Vereinigte Staaten, 45373
- UVMC Cancer Care Center at Upper Valley Medical Center
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Wooster, Ohio, Vereinigte Staaten, 44691
- Cleveland Clinic - Wooster
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Wright-Patterson Afb, Ohio, Vereinigte Staaten, 45433-5529
- United States Air Force Medical Center Wright-Patterson
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Xenia, Ohio, Vereinigte Staaten, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
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Oregon
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Bend, Oregon, Vereinigte Staaten, 97701
- St. Charles Medical Center
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Glesham, Oregon, Vereinigte Staaten, 97030
- Legacy Mount Hood Medical Center
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Milwaukie, Oregon, Vereinigte Staaten, 97222
- Providence Milwaukie Hospital
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Portland, Oregon, Vereinigte Staaten, 97225
- CCOP - Columbia River Oncology Program
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Portland, Oregon, Vereinigte Staaten, 97225
- Providence St. Vincent Medical Center
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Portland, Oregon, Vereinigte Staaten, 97210
- Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center
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Portland, Oregon, Vereinigte Staaten, 97213
- Providence Cancer Center at Providence Portland Medical Center
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Portland, Oregon, Vereinigte Staaten, 97227
- Institute of Oncology at Vilnius University
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Salem, Oregon, Vereinigte Staaten, 97309
- Salem Hospital Regional Cancer Center
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Tualatin, Oregon, Vereinigte Staaten, 97062
- Legacy Meridian Park Hospital
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South Carolina
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Anderson, South Carolina, Vereinigte Staaten, 29621
- Rose Ramer Cancer Clinic at Anderson Area Medical Center
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Charleston, South Carolina, Vereinigte Staaten, 29425
- Hollings Cancer Center at Medical University of South Carolina
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Florence, South Carolina, Vereinigte Staaten, 29506
- McLeod Regional Medical Center
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Greenville, South Carolina, Vereinigte Staaten, 29615
- CCOP - Greenville
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Greenville, South Carolina, Vereinigte Staaten, 29601
- Bon Secours St. Francis Health System
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Greenville, South Carolina, Vereinigte Staaten, 29605
- Greenville Hospital System Cancer Center
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Spartanburg, South Carolina, Vereinigte Staaten, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
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Spartanburg, South Carolina, Vereinigte Staaten, 29304
- CCOP - Upstate Carolina
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Tennessee
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Knoxville, Tennessee, Vereinigte Staaten, 37916
- Thompson Cancer Survival Center
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Texas
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Arlington, Texas, Vereinigte Staaten, 76012
- Arlington Cancer Center - Arlington
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Fort Sam Houston, Texas, Vereinigte Staaten, 78234
- Brooke Army Medical Center
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Lackland AFB, Texas, Vereinigte Staaten, 78236
- Wilford Hall Medical Center
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Lubbock, Texas, Vereinigte Staaten, 79415
- UMC Southwest Cancer and Research Center
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Utah
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Salt Lake City, Utah, Vereinigte Staaten, 84112
- Huntsman Cancer Institute at University of Utah
-
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Virginia
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Danville, Virginia, Vereinigte Staaten, 24541
- Danville Regional Medical Center
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Martinsville, Virginia, Vereinigte Staaten, 24115
- Memorial Hospital of Martinsville and Henry County
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Washington
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Bellingham, Washington, Vereinigte Staaten, 98225
- St. Joseph Hospital Community Cancer Center
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Bremerton, Washington, Vereinigte Staaten, 98310
- Olympic Hematology and Oncology
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Mt. Vernon, Washington, Vereinigte Staaten, 98273
- Cancer Care Center at Skagit Valley Hospital
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Seattle, Washington, Vereinigte Staaten, 98104
- Harborview Medical Center
-
Seattle, Washington, Vereinigte Staaten, 98104
- Fred Hutchinson Cancer Research Center
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Seattle, Washington, Vereinigte Staaten, 98195
- University Cancer Center at University of Washington Medical Center
-
Seattle, Washington, Vereinigte Staaten, 98104
- Group Health Central Hospital
-
Seattle, Washington, Vereinigte Staaten, 98114
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
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Spokane, Washington, Vereinigte Staaten, 99202
- Cancer Care Northwest - Spokane South
-
Spokane, Washington, Vereinigte Staaten, 99204
- Providence Cancer Center at Sacred Heart Medical Center
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Spokane, Washington, Vereinigte Staaten, 99207
- Providence Cancer Center at Holy Family Hospital
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Vancouver, Washington, Vereinigte Staaten, 98668
- Southwest Washington Medical Center Cancer Center
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Wenatchee, Washington, Vereinigte Staaten, 98801
- Central Washington Hospital
-
Wenatchee, Washington, Vereinigte Staaten, 98801
- Wenatchee Valley Clinic
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Yakima, Washington, Vereinigte Staaten, 98902
- North Star Lodge Cancer Center
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Yakima, Washington, Vereinigte Staaten, 98902
- Washington Hematology - Oncology Specialists
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Aktiver 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. |
Aktiver 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Select a regimen based on overall survival
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Correlation of epidermal growth factor receptor polymorphisms and downstream biomarkers with response
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Karen Kelly, MD, University of Colorado, Denver
- Hauptermittler: Roy S. Herbst, MD, PhD, M.D. Anderson Cancer Center
- Hauptermittler: David R. Gandara, MD, University of California, Davis
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen der Atemwege
- Neubildungen
- Lungenkrankheit
- Neubildungen nach Standort
- Neubildungen der Atemwege
- Thoraxneoplasmen
- Karzinom, bronchogen
- Bronchiale Neubildungen
- Lungentumoren
- Karzinom, nicht-kleinzellige Lunge
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antineoplastische Mittel
- Tubulin-Modulatoren
- Antimitotische Mittel
- Mitose-Modulatoren
- Antineoplastische Mittel, Phytogen
- Antineoplastische Mittel, immunologische
- Carboplatin
- Paclitaxel
- Cetuximab
Andere Studien-ID-Nummern
- CDR0000370806
- U10CA032102 (US NIH Stipendium/Vertrag)
- S0342 (Andere Kennung: SWOG)
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