S0342: Paclitaxel, Carboplatin, and Cetuximab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
30. oktober 2012 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
242
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Alaska
-
Anchorage, Alaska, Forenede Stater, 99508
- Alaska Regional Hospital
-
-
Arkansas
-
Little Rock, Arkansas, Forenede Stater, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
-
-
California
-
Berkeley, California, Forenede Stater, 94705
- Alta Bates Comprehensive Cancer Center
-
Burlingame, California, Forenede Stater, 94010
- Peninsula Medical Center
-
Duarte, California, Forenede Stater, 91010
- City of Hope Comprehensive Cancer Center
-
Greenbrae, California, Forenede Stater, 94904
- Sutter Health Western Division Cancer Research Group
-
Greenbrae, California, Forenede Stater, 94904
- Marin Cancer Institute at Marin General Hospital
-
Hayward, California, Forenede Stater, 94545
- Saint Rose Hospital
-
Livermore, California, Forenede Stater, 94550
- Valley Memorial Hospital
-
Los Angeles, California, Forenede Stater, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
-
Oakland, California, Forenede Stater, 94602
- Highland General Hospital
-
Oakland, California, Forenede Stater, 94609
- CCOP - Bay Area Tumor Institute
-
Oakland, California, Forenede Stater, 94609
- Summit Medical Center
-
Palm Springs, California, Forenede Stater, 92262
- Comprehensive Cancer Center at Desert Regional Medical Center
-
Roseville, California, Forenede Stater, 95661
- Sutter Roseville Medical Center
-
Sacramento, California, Forenede Stater, 95816
- Sutter Cancer center
-
Sacramento, California, Forenede Stater, 95819
- Mercy General Hospital
-
Sacramento, California, Forenede Stater, 95817
- University of California Davis Cancer Center
-
San Francisco, California, Forenede Stater, 94118
- California Pacific Medical Center - California Campus
-
San Pablo, California, Forenede Stater, 94806
- J.C. Robinson, M.D. Regional Cancer Center
-
Sana Rosa, California, Forenede Stater, 95405
- CCOP - Santa Rosa Memorial Hospital
-
-
Colorado
-
Denver, Colorado, Forenede Stater, 80220
- Veterans Affairs Medical Center - Denver
-
Denver, Colorado, Forenede Stater, 80204
- St. Anthony Central Hospital
-
Denver, Colorado, Forenede Stater, 80217-3364
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
-
Fort Collins, Colorado, Forenede Stater, 80524
- Poudre Valley Hospital
-
Montrose, Colorado, Forenede Stater, 81401
- Montrose Memorial Hospital Cancer Center
-
Westminster, Colorado, Forenede Stater, 80030
- St. Anthony North Hospital
-
Wheat Ridge, Colorado, Forenede Stater, 80033
- Exempla Lutheran Medical Center
-
-
Georgia
-
Atlanta, Georgia, Forenede Stater, 30309
- Piedmont Hospital
-
Atlanta, Georgia, Forenede Stater, 30342
- Saint Joseph's Hospital of Atlanta
-
Atlanta, Georgia, Forenede Stater, 30342
- CCOP - Atlanta Regional
-
Atlanta, Georgia, Forenede Stater, 30342
- Northside Hospital Cancer Center
-
Augusta, Georgia, Forenede Stater, 30901
- Augusta Oncology Associates
-
Austell, Georgia, Forenede Stater, 30106
- WellStar Cobb Hospital
-
Decatur, Georgia, Forenede Stater, 30033
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
-
Gainesville, Georgia, Forenede Stater, 30501
- Northeast Georgia Medical Center
-
Lawrenceville, Georgia, Forenede Stater, 30045
- Gwinnett Medical Center
-
Marietta, Georgia, Forenede Stater, 30060
- Kennestone Cancer Center at Wellstar Kennestone Hospital
-
Riverdale, Georgia, Forenede Stater, 30274
- Southern Regional Medical Center
-
Savannah, Georgia, Forenede Stater, 31403
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
-
Valdosta, Georgia, Forenede Stater, 31603
- Pearlman Comprehensive Cancer Center at South Georgia Medical Center
-
-
Hawaii
-
Aiea, Hawaii, Forenede Stater, 96701
- Kapiolani Medical Center at Pali Momi
-
Honolula, Hawaii, Forenede Stater, 96813
- Cancer Research Center of Hawaii
-
Honolulu, Hawaii, Forenede Stater, 96826
- Kapiolani Medical Center for Women and Children
-
Honolulu, Hawaii, Forenede Stater, 96813
- OnCare Hawaii, Incorporated - Lusitana
-
Honolulu, Hawaii, Forenede Stater, 96813
- Queen's Cancer Institute at Queen's Medical Center
-
Honolulu, Hawaii, Forenede Stater, 96813
- Straub Clinic and Hospital, Incorporated
-
Honolulu, Hawaii, Forenede Stater, 96817
- OnCare Hawaii, Incorporated - Kuakini
-
Honolulu, Hawaii, Forenede Stater, 96817
- St. Francis Medical Center
-
-
Idaho
-
Boise, Idaho, Forenede Stater, 83712
- St. Luke's Mountain States Tumor Institute - Boise
-
-
Illinois
-
Alton, Illinois, Forenede Stater, 62002
- Saint Anthony's Hospital at Saint Anthony's Health Center
-
Maywood, Illinois, Forenede Stater, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
-
Naperville, Illinois, Forenede Stater, 60540
- Hematology Oncology Consultants Ltd.
-
Naperville, Illinois, Forenede Stater, 60566
- Edward Hospital Cancer Center
-
-
Indiana
-
Beech Grove, Indiana, Forenede Stater, 46107
- St. Francis Hospital and Health Centers
-
-
Iowa
-
Davenport, Iowa, Forenede Stater, 52804
- Genesis Medical Center - West Campus
-
Davenport, Iowa, Forenede Stater, 52803
- Genesis Regional Cancer Center at Genesis Medical Center
-
-
Kansas
-
Kansas City, Kansas, Forenede Stater, 66160
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
-
Salina, Kansas, Forenede Stater, 67401
- Salina Regional Health Center
-
Wichita, Kansas, Forenede Stater, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
-
-
Louisiana
-
New Orleans, Louisiana, Forenede Stater, 70112
- Tulane Cancer Center
-
Shreveport, Louisiana, Forenede Stater, 71101
- Cancer Treatment Center at Christus Schumpert St. Mary Place
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02118
- Cancer Research Center at Boston Medical Center
-
-
Michigan
-
Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan Comprehensive Cancer Center
-
Ann Arbor, Michigan, Forenede Stater, 48106-0995
- St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
-
Ann Arbor, Michigan, Forenede Stater, 48100
- CCOP - Michigan Cancer Research Consortium
-
Battle Creek, Michigan, Forenede Stater, 49017
- Cancer Care Center at Battle Creek Health System
-
Bay City, Michigan, Forenede Stater, 48708
- Bay Regional Medical Center
-
Big Rapids, Michigan, Forenede Stater, 49307
- Mecosta County General Hospital
-
Detroit, Michigan, Forenede Stater, 48202
- Josephine Ford Cancer Center at Henry Ford Health System
-
Flint, Michigan, Forenede Stater, 48532
- Genesys Hurley Cancer Institute
-
Grand Rapids, Michigan, Forenede Stater, 49503
- CCOP - Grand Rapids
-
Grand Rapids, Michigan, Forenede Stater, 49503
- Lacks Cancer Center at Saint Mary's Mercy Medical Center
-
Grand Rapids, Michigan, Forenede Stater, 49503
- Spectrum Health Cancer Care - Butterworth Campus
-
Grand Rapids, Michigan, Forenede Stater, 49506
- Metropolitan Hospital
-
Grand Rapids, Michigan, Forenede Stater, 49506
- Spectrum Health Hospital - Blodgett Campus
-
Holland, Michigan, Forenede Stater, 49423
- Holland Community Hospital
-
Mount Clemens, Michigan, Forenede Stater, 48043
- Mount Clemens General Hospital
-
Muskegon, Michigan, Forenede Stater, 49443
- Hackley Hospital
-
Petoskey, Michigan, Forenede Stater, 49770
- Northern Michigan Hospital
-
Pontiac, Michigan, Forenede Stater, 48341-2985
- St. Joseph Mercy Hospital
-
Saginaw, Michigan, Forenede Stater, 48601
- Seton Cancer Institute - Saginaw
-
Traverse City, Michigan, Forenede Stater, 49684
- Munson Medical Center
-
Warren, Michigan, Forenede Stater, 48903
- St. John Macomb Hospital
-
-
Mississippi
-
Jackson, Mississippi, Forenede Stater, 39216
- University of Mississippi Medical Center
-
Kessler AFB, Mississippi, Forenede Stater, 39534-2519
- Keesler Medical Center - Keesler Air Force Base
-
-
Missouri
-
Cape Girardeau, Missouri, Forenede Stater, 63701
- St. Francis Medical Center
-
Gape Girardeau, Missouri, Forenede Stater, 63701
- Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
-
Joplin, Missouri, Forenede Stater, 64804
- Freeman Cancer Institute at Freeman Health System
-
Springfield, Missouri, Forenede Stater, 65804
- St. John's Regional Health Center
-
Springfield, Missouri, Forenede Stater, 65807
- Hulston Cancer Center at Cox Medical Center South
-
St. Louis, Missouri, Forenede Stater, 63141
- CCOP - St. Louis-Cape Girardeau
-
St. Louis, Missouri, Forenede Stater, 63141
- David C. Pratt Cancer Center at St. John's Mercy
-
-
Montana
-
Billings, Montana, Forenede Stater, 59101
- CCOP - Montana Cancer Consortium
-
Great Falls, Montana, Forenede Stater, 59405
- Great Falls Clinic
-
Great Falls, Montana, Forenede Stater, 59405
- Big Sky Oncology
-
Great Falls, Montana, Forenede Stater, 59405
- Sletten Regional Cancer Institute
-
-
New Jersey
-
Ridgewood, New Jersey, Forenede Stater, 07450
- Valley Hospital - Ridgewood
-
-
New York
-
Glens Falls, New York, Forenede Stater, 12801
- Adirondack Cancer Care
-
Rochester, New York, Forenede Stater, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
-
-
North Carolina
-
Charlotte, North Carolina, Forenede Stater, 28203
- Blumenthal Cancer Center at Carolinas Medical Center
-
Goldsboro, North Carolina, Forenede Stater, 27534
- Wayne Memorial Hospital, Incorporated
-
Hendersonville, North Carolina, Forenede Stater, 28791
- Pardee Memorial Hospital
-
Rutherfordton, North Carolina, Forenede Stater, 28139
- Rutherford Hospital
-
-
Ohio
-
Akron, Ohio, Forenede Stater, 44307
- McDowell Cancer Center at Akron General Medical Center
-
Cincinnati, Ohio, Forenede Stater, 45220
- Tri-Health Good Samaritan Hospital
-
Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Taussig Cancer Center
-
Dayton, Ohio, Forenede Stater, 45428
- Veterans Affairs Medical Center - Dayton
-
Dayton, Ohio, Forenede Stater, 45405
- Grandview Hospital
-
Dayton, Ohio, Forenede Stater, 45406
- Good Samaritan Hospital
-
Dayton, Ohio, Forenede Stater, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
-
Dayton, Ohio, Forenede Stater, 45415
- Samaritan North Cancer Care Center
-
Dayton, Ohio, Forenede Stater, 45429
- CCOP - Dayton
-
Independence, Ohio, Forenede Stater, 44131
- Community Oncology Group - Independence
-
Kettering, Ohio, Forenede Stater, 45429
- Charles F. Kettering Memorial Hospital
-
Mansfield, Ohio, Forenede Stater, 44903
- MedCentral - Mansfield Hospital
-
Middletown, Ohio, Forenede Stater, 45044
- Middletown Regional Hospital
-
Troy, Ohio, Forenede Stater, 45373
- UVMC Cancer Care Center at Upper Valley Medical Center
-
Wooster, Ohio, Forenede Stater, 44691
- Cleveland Clinic - Wooster
-
Wright-Patterson Afb, Ohio, Forenede Stater, 45433-5529
- United States Air Force Medical Center Wright-Patterson
-
Xenia, Ohio, Forenede Stater, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
-
-
Oregon
-
Bend, Oregon, Forenede Stater, 97701
- St. Charles Medical Center
-
Glesham, Oregon, Forenede Stater, 97030
- Legacy Mount Hood Medical Center
-
Milwaukie, Oregon, Forenede Stater, 97222
- Providence Milwaukie Hospital
-
Portland, Oregon, Forenede Stater, 97225
- CCOP - Columbia River Oncology Program
-
Portland, Oregon, Forenede Stater, 97225
- Providence St. Vincent Medical Center
-
Portland, Oregon, Forenede Stater, 97210
- Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center
-
Portland, Oregon, Forenede Stater, 97213
- Providence Cancer Center at Providence Portland Medical Center
-
Portland, Oregon, Forenede Stater, 97227
- Institute of Oncology at Vilnius University
-
Salem, Oregon, Forenede Stater, 97309
- Salem Hospital Regional Cancer Center
-
Tualatin, Oregon, Forenede Stater, 97062
- Legacy Meridian Park Hospital
-
-
South Carolina
-
Anderson, South Carolina, Forenede Stater, 29621
- Rose Ramer Cancer Clinic at Anderson Area Medical Center
-
Charleston, South Carolina, Forenede Stater, 29425
- Hollings Cancer Center at Medical University of South Carolina
-
Florence, South Carolina, Forenede Stater, 29506
- McLeod Regional Medical Center
-
Greenville, South Carolina, Forenede Stater, 29615
- CCOP - Greenville
-
Greenville, South Carolina, Forenede Stater, 29601
- Bon Secours St. Francis Health System
-
Greenville, South Carolina, Forenede Stater, 29605
- Greenville Hospital System Cancer Center
-
Spartanburg, South Carolina, Forenede Stater, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
-
Spartanburg, South Carolina, Forenede Stater, 29304
- CCOP - Upstate Carolina
-
-
Tennessee
-
Knoxville, Tennessee, Forenede Stater, 37916
- Thompson Cancer Survival Center
-
-
Texas
-
Arlington, Texas, Forenede Stater, 76012
- Arlington Cancer Center - Arlington
-
Fort Sam Houston, Texas, Forenede Stater, 78234
- Brooke Army Medical Center
-
Lackland AFB, Texas, Forenede Stater, 78236
- Wilford Hall Medical Center
-
Lubbock, Texas, Forenede Stater, 79415
- UMC Southwest Cancer and Research Center
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater, 84112
- Huntsman Cancer Institute at University of Utah
-
-
Virginia
-
Danville, Virginia, Forenede Stater, 24541
- Danville Regional Medical Center
-
Martinsville, Virginia, Forenede Stater, 24115
- Memorial Hospital of Martinsville and Henry County
-
-
Washington
-
Bellingham, Washington, Forenede Stater, 98225
- St. Joseph Hospital Community Cancer Center
-
Bremerton, Washington, Forenede Stater, 98310
- Olympic Hematology and Oncology
-
Mt. Vernon, Washington, Forenede Stater, 98273
- Cancer Care Center at Skagit Valley Hospital
-
Seattle, Washington, Forenede Stater, 98104
- Harborview Medical Center
-
Seattle, Washington, Forenede Stater, 98104
- Fred Hutchinson Cancer Research Center
-
Seattle, Washington, Forenede Stater, 98195
- University Cancer Center at University of Washington Medical Center
-
Seattle, Washington, Forenede Stater, 98104
- Group Health Central Hospital
-
Seattle, Washington, Forenede Stater, 98114
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
-
Spokane, Washington, Forenede Stater, 99202
- Cancer Care Northwest - Spokane South
-
Spokane, Washington, Forenede Stater, 99204
- Providence Cancer Center at Sacred Heart Medical Center
-
Spokane, Washington, Forenede Stater, 99207
- Providence Cancer Center at Holy Family Hospital
-
Vancouver, Washington, Forenede Stater, 98668
- Southwest Washington Medical Center Cancer Center
-
Wenatchee, Washington, Forenede Stater, 98801
- Central Washington Hospital
-
Wenatchee, Washington, Forenede Stater, 98801
- Wenatchee Valley Clinic
-
Yakima, Washington, Forenede Stater, 98902
- North Star Lodge Cancer Center
-
Yakima, Washington, Forenede Stater, 98902
- Washington Hematology - Oncology Specialists
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Select a regimen based on overall survival
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Correlation of epidermal growth factor receptor polymorphisms and downstream biomarkers with response
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Karen Kelly, MD, University of Colorado, Denver
- Ledende efterforsker: Roy S. Herbst, MD, PhD, M.D. Anderson Cancer Center
- Ledende efterforsker: David R. Gandara, MD, University of California, Davis
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2004
Primær færdiggørelse (Faktiske)
1. august 2007
Studieafslutning (Faktiske)
1. juli 2011
Datoer for studieregistrering
Først indsendt
10. juni 2004
Først indsendt, der opfyldte QC-kriterier
10. juni 2004
Først opslået (Skøn)
11. juni 2004
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
1. november 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. oktober 2012
Sidst verificeret
1. oktober 2012
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karcinom, ikke-småcellet lunge
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, fytogene
- Antineoplastiske midler, immunologiske
- Carboplatin
- Paclitaxel
- Cetuximab
Andre undersøgelses-id-numre
- CDR0000370806
- U10CA032102 (U.S. NIH-bevilling/kontrakt)
- S0342 (Anden identifikator: SWOG)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Lungekræft
-
Seoul National University HospitalAfsluttet
-
Seoul National University HospitalAfsluttet
-
Yonsei UniversityAfsluttetOne Lung VentilationKorea, Republikken
-
Sichuan UniversityWest China HospitalMidlertidigt ikke tilgængeligOne Lung Ventilation
-
Chinese Chronic Respiratory Disease Research NetworkRekruttering
-
Mansoura UniversityAfsluttetOne Lung VentilationEgypten
-
Dokuz Eylul UniversityAfsluttetOne Lung VentilationKalkun
-
Luca BrazziA.O.U. Città della Salute e della Scienza - Molinette HospitalIkke rekrutterer endnuIntubationskomplikation | One Lung Ventilation
-
Ankara Ataturk Sanatorium Training and Research...Ikke rekrutterer endnuOne-lung Ventilation (OLV)Tyrkiet (Türkiye)
-
Joseph D. TobiasAfsluttetOne-lung Ventilation (OLV)Forenede Stater
Kliniske forsøg med cetuximab
-
Amsterdam UMC, location VUmcRadboud University Medical Center; University Medical Center GroningenAfsluttetMetastatisk tyktarmskræftHolland
-
University Medical Center GroningenUMC Utrecht; Erasmus Medical CenterRekrutteringPlanocellulært karcinom i hoved og hals | MarginvurderingHolland
-
Zhejiang UniversityRekrutteringKolorektale neoplasmer | Fruquintinib | BRAF | RAS | CetuximabβKina
-
Meng QiuIkke rekrutterer endnuCapecitabin | Kolorektal cancer (CRC) | CetuximabKina
-
West China HospitalFirst Affiliated Hospital of Chongqing Medical UniversityRekrutteringColo-rektal cancer | Capecitabin | CetuximabKina
-
Shanghai Ninth People's Hospital Affiliated to...RekrutteringTilbagevendende/metastatisk pladecellekræft i hoved og halsKina
-
Eben RosenthalNational Cancer Institute (NCI)AfsluttetAdenocarcinom i bugspytkirtlenForenede Stater
-
HiberCell, Inc.AfsluttetKolorektal cancerForenede Stater, Puerto Rico, Tyskland, Frankrig
-
Merck KGaA, Darmstadt, GermanyAfsluttetTidligere ubehandlet metastatisk tyktarmskræftFrankrig, Italien, Polen, Tyskland, Hong Kong, Østrig, Brasilien, Israel, Grækenland, Argentina, Thailand, Belgien, Australien, Mexico
-
Arbeitsgemeinschaft medikamentoese TumortherapieMerck Sharp & Dohme LLCAfsluttet