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S0342: Paclitaxel, Carboplatin, and Cetuximab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

30. oktober 2012 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Lungekreft

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

242

Fase

Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Forente stater
- Alaska
  - Anchorage, Alaska, Forente stater, 99508
    - Alaska Regional Hospital
- Arkansas
  - Little Rock, Arkansas, Forente stater, 72205
    - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- California
  - Berkeley, California, Forente stater, 94705
    - Alta Bates Comprehensive Cancer Center
  - Burlingame, California, Forente stater, 94010
    - Peninsula Medical Center
  - Duarte, California, Forente stater, 91010
    - City of Hope Comprehensive Cancer Center
  - Greenbrae, California, Forente stater, 94904
    - Sutter Health Western Division Cancer Research Group
  - Greenbrae, California, Forente stater, 94904
    - Marin Cancer Institute at Marin General Hospital
  - Hayward, California, Forente stater, 94545
    - Saint Rose Hospital
  - Livermore, California, Forente stater, 94550
    - Valley Memorial Hospital
  - Los Angeles, California, Forente stater, 90033-0804
    - USC/Norris Comprehensive Cancer Center and Hospital
  - Oakland, California, Forente stater, 94602
    - Highland General Hospital
  - Oakland, California, Forente stater, 94609
    - CCOP - Bay Area Tumor Institute
  - Oakland, California, Forente stater, 94609
    - Summit Medical Center
  - Palm Springs, California, Forente stater, 92262
    - Comprehensive Cancer Center at Desert Regional Medical Center
  - Roseville, California, Forente stater, 95661
    - Sutter Roseville Medical Center
  - Sacramento, California, Forente stater, 95816
    - Sutter Cancer center
  - Sacramento, California, Forente stater, 95819
    - Mercy General Hospital
  - Sacramento, California, Forente stater, 95817
    - University of California Davis Cancer Center
  - San Francisco, California, Forente stater, 94118
    - California Pacific Medical Center - California Campus
  - San Pablo, California, Forente stater, 94806
    - J.C. Robinson, M.D. Regional Cancer Center
  - Sana Rosa, California, Forente stater, 95405
    - CCOP - Santa Rosa Memorial Hospital
- Colorado
  - Denver, Colorado, Forente stater, 80220
    - Veterans Affairs Medical Center - Denver
  - Denver, Colorado, Forente stater, 80204
    - St. Anthony Central Hospital
  - Denver, Colorado, Forente stater, 80217-3364
    - University of Colorado Cancer Center at University of Colorado Health Sciences Center
  - Fort Collins, Colorado, Forente stater, 80524
    - Poudre Valley Hospital
  - Montrose, Colorado, Forente stater, 81401
    - Montrose Memorial Hospital Cancer Center
  - Westminster, Colorado, Forente stater, 80030
    - St. Anthony North Hospital
  - Wheat Ridge, Colorado, Forente stater, 80033
    - Exempla Lutheran Medical Center
- Georgia
  - Atlanta, Georgia, Forente stater, 30309
    - Piedmont Hospital
  - Atlanta, Georgia, Forente stater, 30342
    - Saint Joseph's Hospital of Atlanta
  - Atlanta, Georgia, Forente stater, 30342
    - CCOP - Atlanta Regional
  - Atlanta, Georgia, Forente stater, 30342
    - Northside Hospital Cancer Center
  - Augusta, Georgia, Forente stater, 30901
    - Augusta Oncology Associates
  - Austell, Georgia, Forente stater, 30106
    - WellStar Cobb Hospital
  - Decatur, Georgia, Forente stater, 30033
    - Charles B. Eberhart Cancer Center at DeKalb Medical Center
  - Gainesville, Georgia, Forente stater, 30501
    - Northeast Georgia Medical Center
  - Lawrenceville, Georgia, Forente stater, 30045
    - Gwinnett Medical Center
  - Marietta, Georgia, Forente stater, 30060
    - Kennestone Cancer Center at Wellstar Kennestone Hospital
  - Riverdale, Georgia, Forente stater, 30274
    - Southern Regional Medical Center
  - Savannah, Georgia, Forente stater, 31403
    - Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
  - Valdosta, Georgia, Forente stater, 31603
    - Pearlman Comprehensive Cancer Center at South Georgia Medical Center
- Hawaii
  - Aiea, Hawaii, Forente stater, 96701
    - Kapiolani Medical Center at Pali Momi
  - Honolula, Hawaii, Forente stater, 96813
    - Cancer Research Center of Hawaii
  - Honolulu, Hawaii, Forente stater, 96826
    - Kapiolani Medical Center for Women and Children
  - Honolulu, Hawaii, Forente stater, 96813
    - OnCare Hawaii, Incorporated - Lusitana
  - Honolulu, Hawaii, Forente stater, 96813
    - Queen's Cancer Institute at Queen's Medical Center
  - Honolulu, Hawaii, Forente stater, 96813
    - Straub Clinic and Hospital, Incorporated
  - Honolulu, Hawaii, Forente stater, 96817
    - OnCare Hawaii, Incorporated - Kuakini
  - Honolulu, Hawaii, Forente stater, 96817
    - St. Francis Medical Center
- Idaho
  - Boise, Idaho, Forente stater, 83712
    - St. Luke's Mountain States Tumor Institute - Boise
- Illinois
  - Alton, Illinois, Forente stater, 62002
    - Saint Anthony's Hospital at Saint Anthony's Health Center
  - Maywood, Illinois, Forente stater, 60153
    - Cardinal Bernardin Cancer Center at Loyola University Medical Center
  - Naperville, Illinois, Forente stater, 60540
    - Hematology Oncology Consultants Ltd.
  - Naperville, Illinois, Forente stater, 60566
    - Edward Hospital Cancer Center
- Indiana
  - Beech Grove, Indiana, Forente stater, 46107
    - St. Francis Hospital and Health Centers
- Iowa
  - Davenport, Iowa, Forente stater, 52804
    - Genesis Medical Center - West Campus
  - Davenport, Iowa, Forente stater, 52803
    - Genesis Regional Cancer Center at Genesis Medical Center
- Kansas
  - Kansas City, Kansas, Forente stater, 66160
    - Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
  - Salina, Kansas, Forente stater, 67401
    - Salina Regional Health Center
  - Wichita, Kansas, Forente stater, 67214
    - Via Christi Cancer Center at Via Christi Regional Medical Center
- Louisiana
  - New Orleans, Louisiana, Forente stater, 70112
    - Tulane Cancer Center
  - Shreveport, Louisiana, Forente stater, 71101
    - Cancer Treatment Center at Christus Schumpert St. Mary Place
- Massachusetts
  - Boston, Massachusetts, Forente stater, 02118
    - Cancer Research Center at Boston Medical Center
- Michigan
  - Ann Arbor, Michigan, Forente stater, 48109
    - University of Michigan Comprehensive Cancer Center
  - Ann Arbor, Michigan, Forente stater, 48106-0995
    - St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
  - Ann Arbor, Michigan, Forente stater, 48100
    - CCOP - Michigan Cancer Research Consortium
  - Battle Creek, Michigan, Forente stater, 49017
    - Cancer Care Center at Battle Creek Health System
  - Bay City, Michigan, Forente stater, 48708
    - Bay Regional Medical Center
  - Big Rapids, Michigan, Forente stater, 49307
    - Mecosta County General Hospital
  - Detroit, Michigan, Forente stater, 48202
    - Josephine Ford Cancer Center at Henry Ford Health System
  - Flint, Michigan, Forente stater, 48532
    - Genesys Hurley Cancer Institute
  - Grand Rapids, Michigan, Forente stater, 49503
    - CCOP - Grand Rapids
  - Grand Rapids, Michigan, Forente stater, 49503
    - Lacks Cancer Center at Saint Mary's Mercy Medical Center
  - Grand Rapids, Michigan, Forente stater, 49503
    - Spectrum Health Cancer Care - Butterworth Campus
  - Grand Rapids, Michigan, Forente stater, 49506
    - Metropolitan Hospital
  - Grand Rapids, Michigan, Forente stater, 49506
    - Spectrum Health Hospital - Blodgett Campus
  - Holland, Michigan, Forente stater, 49423
    - Holland Community Hospital
  - Mount Clemens, Michigan, Forente stater, 48043
    - Mount Clemens General Hospital
  - Muskegon, Michigan, Forente stater, 49443
    - Hackley Hospital
  - Petoskey, Michigan, Forente stater, 49770
    - Northern Michigan Hospital
  - Pontiac, Michigan, Forente stater, 48341-2985
    - St. Joseph Mercy Hospital
  - Saginaw, Michigan, Forente stater, 48601
    - Seton Cancer Institute - Saginaw
  - Traverse City, Michigan, Forente stater, 49684
    - Munson Medical Center
  - Warren, Michigan, Forente stater, 48903
    - St. John Macomb Hospital
- Mississippi
  - Jackson, Mississippi, Forente stater, 39216
    - University of Mississippi Medical Center
  - Kessler AFB, Mississippi, Forente stater, 39534-2519
    - Keesler Medical Center - Keesler Air Force Base
- Missouri
  - Cape Girardeau, Missouri, Forente stater, 63701
    - St. Francis Medical Center
  - Gape Girardeau, Missouri, Forente stater, 63701
    - Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
  - Joplin, Missouri, Forente stater, 64804
    - Freeman Cancer Institute at Freeman Health System
  - Springfield, Missouri, Forente stater, 65804
    - St. John's Regional Health Center
  - Springfield, Missouri, Forente stater, 65807
    - Hulston Cancer Center at Cox Medical Center South
  - St. Louis, Missouri, Forente stater, 63141
    - CCOP - St. Louis-Cape Girardeau
  - St. Louis, Missouri, Forente stater, 63141
    - David C. Pratt Cancer Center at St. John's Mercy
- Montana
  - Billings, Montana, Forente stater, 59101
    - CCOP - Montana Cancer Consortium
  - Great Falls, Montana, Forente stater, 59405
    - Great Falls Clinic
  - Great Falls, Montana, Forente stater, 59405
    - Big Sky Oncology
  - Great Falls, Montana, Forente stater, 59405
    - Sletten Regional Cancer Institute
- New Jersey
  - Ridgewood, New Jersey, Forente stater, 07450
    - Valley Hospital - Ridgewood
- New York
  - Glens Falls, New York, Forente stater, 12801
    - Adirondack Cancer Care
  - Rochester, New York, Forente stater, 14642
    - James P. Wilmot Cancer Center at University of Rochester Medical Center
- North Carolina
  - Charlotte, North Carolina, Forente stater, 28203
    - Blumenthal Cancer Center at Carolinas Medical Center
  - Goldsboro, North Carolina, Forente stater, 27534
    - Wayne Memorial Hospital, Incorporated
  - Hendersonville, North Carolina, Forente stater, 28791
    - Pardee Memorial Hospital
  - Rutherfordton, North Carolina, Forente stater, 28139
    - Rutherford Hospital
- Ohio
  - Akron, Ohio, Forente stater, 44307
    - McDowell Cancer Center at Akron General Medical Center
  - Cincinnati, Ohio, Forente stater, 45220
    - Tri-Health Good Samaritan Hospital
  - Cleveland, Ohio, Forente stater, 44195
    - Cleveland Clinic Taussig Cancer Center
  - Dayton, Ohio, Forente stater, 45428
    - Veterans Affairs Medical Center - Dayton
  - Dayton, Ohio, Forente stater, 45405
    - Grandview Hospital
  - Dayton, Ohio, Forente stater, 45406
    - Good Samaritan Hospital
  - Dayton, Ohio, Forente stater, 45409
    - David L. Rike Cancer Center at Miami Valley Hospital
  - Dayton, Ohio, Forente stater, 45415
    - Samaritan North Cancer Care Center
  - Dayton, Ohio, Forente stater, 45429
    - CCOP - Dayton
  - Independence, Ohio, Forente stater, 44131
    - Community Oncology Group - Independence
  - Kettering, Ohio, Forente stater, 45429
    - Charles F. Kettering Memorial Hospital
  - Mansfield, Ohio, Forente stater, 44903
    - MedCentral - Mansfield Hospital
  - Middletown, Ohio, Forente stater, 45044
    - Middletown Regional Hospital
  - Troy, Ohio, Forente stater, 45373
    - UVMC Cancer Care Center at Upper Valley Medical Center
  - Wooster, Ohio, Forente stater, 44691
    - Cleveland Clinic - Wooster
  - Wright-Patterson Afb, Ohio, Forente stater, 45433-5529
    - United States Air Force Medical Center Wright-Patterson
  - Xenia, Ohio, Forente stater, 45385
    - Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Oregon
  - Bend, Oregon, Forente stater, 97701
    - St. Charles Medical Center
  - Glesham, Oregon, Forente stater, 97030
    - Legacy Mount Hood Medical Center
  - Milwaukie, Oregon, Forente stater, 97222
    - Providence Milwaukie Hospital
  - Portland, Oregon, Forente stater, 97225
    - CCOP - Columbia River Oncology Program
  - Portland, Oregon, Forente stater, 97225
    - Providence St. Vincent Medical Center
  - Portland, Oregon, Forente stater, 97210
    - Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center
  - Portland, Oregon, Forente stater, 97213
    - Providence Cancer Center at Providence Portland Medical Center
  - Portland, Oregon, Forente stater, 97227
    - Institute of Oncology at Vilnius University
  - Salem, Oregon, Forente stater, 97309
    - Salem Hospital Regional Cancer Center
  - Tualatin, Oregon, Forente stater, 97062
    - Legacy Meridian Park Hospital
- South Carolina
  - Anderson, South Carolina, Forente stater, 29621
    - Rose Ramer Cancer Clinic at Anderson Area Medical Center
  - Charleston, South Carolina, Forente stater, 29425
    - Hollings Cancer Center at Medical University of South Carolina
  - Florence, South Carolina, Forente stater, 29506
    - McLeod Regional Medical Center
  - Greenville, South Carolina, Forente stater, 29615
    - CCOP - Greenville
  - Greenville, South Carolina, Forente stater, 29601
    - Bon Secours St. Francis Health System
  - Greenville, South Carolina, Forente stater, 29605
    - Greenville Hospital System Cancer Center
  - Spartanburg, South Carolina, Forente stater, 29303
    - Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
  - Spartanburg, South Carolina, Forente stater, 29304
    - CCOP - Upstate Carolina
- Tennessee
  - Knoxville, Tennessee, Forente stater, 37916
    - Thompson Cancer Survival Center
- Texas
  - Arlington, Texas, Forente stater, 76012
    - Arlington Cancer Center - Arlington
  - Fort Sam Houston, Texas, Forente stater, 78234
    - Brooke Army Medical Center
  - Lackland AFB, Texas, Forente stater, 78236
    - Wilford Hall Medical Center
  - Lubbock, Texas, Forente stater, 79415
    - UMC Southwest Cancer and Research Center
- Utah
  - Salt Lake City, Utah, Forente stater, 84112
    - Huntsman Cancer Institute at University of Utah
- Virginia
  - Danville, Virginia, Forente stater, 24541
    - Danville Regional Medical Center
  - Martinsville, Virginia, Forente stater, 24115
    - Memorial Hospital of Martinsville and Henry County
- Washington
  - Bellingham, Washington, Forente stater, 98225
    - St. Joseph Hospital Community Cancer Center
  - Bremerton, Washington, Forente stater, 98310
    - Olympic Hematology and Oncology
  - Mt. Vernon, Washington, Forente stater, 98273
    - Cancer Care Center at Skagit Valley Hospital
  - Seattle, Washington, Forente stater, 98104
    - Harborview Medical Center
  - Seattle, Washington, Forente stater, 98104
    - Fred Hutchinson Cancer Research Center
  - Seattle, Washington, Forente stater, 98195
    - University Cancer Center at University of Washington Medical Center
  - Seattle, Washington, Forente stater, 98104
    - Group Health Central Hospital
  - Seattle, Washington, Forente stater, 98114
    - Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
  - Spokane, Washington, Forente stater, 99202
    - Cancer Care Northwest - Spokane South
  - Spokane, Washington, Forente stater, 99204
    - Providence Cancer Center at Sacred Heart Medical Center
  - Spokane, Washington, Forente stater, 99207
    - Providence Cancer Center at Holy Family Hospital
  - Vancouver, Washington, Forente stater, 98668
    - Southwest Washington Medical Center Cancer Center
  - Wenatchee, Washington, Forente stater, 98801
    - Central Washington Hospital
  - Wenatchee, Washington, Forente stater, 98801
    - Wenatchee Valley Clinic
  - Yakima, Washington, Forente stater, 98902
    - North Star Lodge Cancer Center
  - Yakima, Washington, Forente stater, 98902
    - Washington Hematology - Oncology Specialists

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Tildeling: Randomisert
Intervensjonsmodell: Parallell tildeling
Masking: Ingen (Open Label)

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm	Intervensjon / Behandling
Aktiv komparator: 2	Legemiddel: cetuximab 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. Legemiddel: carboplatin 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 Legemiddel: paclitaxel 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	Legemiddel: cetuximab 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. Legemiddel: carboplatin 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 Legemiddel: paclitaxel 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.

Deltakergruppe / Arm

Intervensjon / Behandling

Aktiv komparator: 2

Legemiddel: cetuximab

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.

Legemiddel: carboplatin

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

Legemiddel: paclitaxel

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

Legemiddel: cetuximab

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.

Legemiddel: carboplatin

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

Legemiddel: paclitaxel

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.

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	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	Tiltaksbeskrivelse	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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Southwest Oncology Group

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

Hovedetterforsker: Karen Kelly, MD, University of Colorado, Denver
Hovedetterforsker: Roy S. Herbst, MD, PhD, M.D. Anderson Cancer Center
Hovedetterforsker: David R. Gandara, MD, University of California, Davis

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2004

Primær fullføring (Faktiske)

1. august 2007

Studiet fullført (Faktiske)

1. juli 2011

Datoer for studieregistrering

Først innsendt

10. juni 2004

Først innsendt som oppfylte QC-kriteriene

10. juni 2004

Først lagt ut (Anslag)

11. juni 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

1. november 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. oktober 2012

Sist bekreftet

1. oktober 2012

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

CDR0000370806
U10CA032102 (U.S. NIH-stipend/kontrakt)
S0342 (Annen identifikator: SWOG)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Lungekreft

Konya City Hospital

Fullført

Postoperativ membranfunksjon i pediatrisk laparoskopisk abdominal kirurgi ved bruk av samsvar og kikk styrt av lunge -ultralyd

Peep By Lung Ultralyd | Peep med dynamisk etterlevelse

Tyrkia
Trakya University

Har ikke rekruttert ennå

Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation

Thoraxkirurgi | Endobronkial intubasjon | One Lung Ventillation (OLV) | Dobbel Lumen Tube Intubasjon
Yonsei University

Fullført

Effekter av dexmedetomidin på respirasjonsmekanikk og oksygenering under én lungeventilasjon med kronisk obstruktiv lungesykdom

KOLS, One Lung Ventilation
Kayseri City Hospital

Fullført

Effekt av Erector Spinae Plane-blokk på cerebral oksygenering under ett-lunge ventilasjon

Cerebral desaturasjon | Nær infrarød spektroskopi | One Lung Ventillation (OLV) | Intraoperativ smertestillende bruk | Erector Spina Plan Block

Tyrkia (Türkiye)
Sichuan University

Har ikke rekruttert ennå

Sikkerhet og effekt av stråleterapi kombinert med immunokjemoterapi hos pre-behandlede SCLC-pasienter med levermetastaser

Lung Cancer (SCLC)

Kina
Universitas Jenderal Soedirman
RS Prof. Dr. Margono Soekardjo Purwokerto

Fullført

Sammenheng mellom ettlungeventilasjon og markører for hjerteskade (troponin T og I) i torakale kirurgiske inngrep (OLVTIS) (OLVTIS)

Thorax anestesi | One Lung Ventillation (OLV)

Indonesia
The Cleveland Clinic

Tilbaketrukket

Bruken av konstantstrømningsteknikk for å bestemme det nedre bøyepunktet for trykk-volumkurven og indre PEEP under en-lungeventilasjon

One Lung Ventillation (OLV) | To lungeventilasjon (TLV) | Positivt End Expiratory Pressure (PEEP) | Null sluttekspirasjonstrykk (ZEEP)
Novartis Pharmaceuticals

Fullført

Everolimus Plus Best Supportive Care vs Placebo Plus Best Supportive Care i behandling av pasienter med avanserte nevroendokrine svulster (GI eller Lung Origin) (RADIANT-4)

Nevroendokrine svulster | Avansert NET av GI Origin | Advanced NET of Lung Origin

Forente stater, Colombia, Italia, Taiwan, Storbritannia, Belgia, Tsjekkia, Tyskland, Japan, Saudi-Arabia, Canada, Nederland, Spania, Korea, Republikken, Libanon, Østerrike, Kina, Hellas, Sør-Afrika, Thailand, Ungarn, Tyrkia, Polen, Slov... og mer
Assiut University

Har ikke rekruttert ennå

Polypropylen vs polyglactin i suturering av lungen

Lungekreft | Lungeskade | Bleb Lung
RenJi Hospital

Rekruttering

Prospective Genomics Initiative on Multiple Synchronous Lung Cancer (PGI-MSLC)

Multiple Synchronous Lung Cancers (MSLC)

Kina

Kliniske studier på cetuximab

University Medical Center Groningen
UMC Utrecht; Erasmus Medical Center

Rekruttering

Bildeveiledet kirurgi for marginvurdering av hode- og nakkekreft ved bruk av Cetuximab-IRDye800CW conjugate (ICON)

Plateepitelkarsinom i hode og nakke | Marginvurdering

Nederland
Zhejiang University

Rekruttering

Sikkerhet og effekt av Cetuximab beta pluss Fruquintinib med eller uten immunsjekkpunkthemmere i første-linje behandling av RAS/BRAF villtype uopererbar metastatisk tykktarmskreft (concept)

Kolorektale neoplasmer | Fruquintinib | BRAF | RAS | Cetuximabβ

Kina
Amsterdam UMC, location VUmc
Radboud University Medical Center; University Medical Center Groningen

Avsluttet

Bildeveiledet behandlingsoptimalisering med Cetuximab for pasienter med metastatisk tykktarmskreft (IMPACT-CRC)

Metastatisk tykktarmskreft

Nederland
Meng Qiu

Har ikke rekruttert ennå

Førstelinjebehandling av MCapOX + Cetuximab vs. MFOLFOX6 + Cetuximab for RAS/BRAF villtype, MSS, uoperabel venstresidig MCRC: en multisenter, randomisert, kontrollert, fase III-studie (CAPCET-III)

Capecitabin | Kolorektal kreft (CRC) | Cetuximab

Kina
West China Hospital
First Affiliated Hospital of Chongqing Medical University

Rekruttering

Førstelinje mCapOX+Cetuximab vs. mFOLFOX6+Cetuximab for metastatisk venstresidig CRC med villtype RAS/BRAF-gener (CAPCET)

Tykktarmskreft | Capecitabin | Cetuximab

Kina
Eben Rosenthal
National Cancer Institute (NCI)

Avsluttet

Cetuximab-IRDye 800CW og intraoperativ bildediagnostikk for å finne kreft i bukspyttkjertelen hos pasienter som gjennomgår kirurgi

Adenokarsinom i bukspyttkjertelen

Forente stater
HiberCell, Inc.

Avsluttet

Studie av Imprime PGG® i kombinasjon med Cetuximab hos personer med tilbakevendende eller progressiv KRAS villtype tykktarmskreft (PRIMUS)

Tykktarmskreft

Forente stater, Puerto Rico, Tyskland, Frankrike
Merck KGaA, Darmstadt, Germany

Fullført

Studie for å evaluere effektiviteten og sikkerheten til FOLFOX-4 Plus Cetuximab versus UFOX Plus Cetuximab. (FUTURE)

Tidligere ubehandlet metastatisk tykktarmskreft

Frankrike, Italia, Polen, Tyskland, Hong Kong, Østerrike, Brasil, Israel, Hellas, Argentina, Thailand, Belgia, Australia, Mexico
Arbeitsgemeinschaft medikamentoese Tumortherapie
Merck Sharp & Dohme LLC

Fullført

Biomarkørrettet behandling ved metastatisk kolorektal kreft

Metastatisk tykktarmskreft

Østerrike
Chinese PLA General Hospital

Har ikke rekruttert ennå

Effektiviteten av Tunlametinib i kombinasjon med anti-EGFR-monoklonalt antistoff hos pasienter med RAS-mutert avansert gastrointestinal malignitet

Behandling for avansert tykktarmskreft | Behandling for avansert bukspyttkjertelkreft

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)

Studieoversikt

Status

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Studietype

Registrering (Faktiske)

Fase

Kontakter og plasseringer

Studiesteder

Deltakelseskriterier

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Tar imot friske frivillige

Kjønn som er kvalifisert for studier

Beskrivelse

Studieplan

Hvordan er studiet utformet?

Designdetaljer

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm

Intervensjon / Behandling

Hva måler studien?

Primære resultatmål

Resultatmål

Tiltaksbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Tiltaksbeskrivelse

Tidsramme

Samarbeidspartnere og etterforskere

Sponsor

Samarbeidspartnere

Etterforskere

Publikasjoner og nyttige lenker

Generelle publikasjoner

Studierekorddatoer

Studer hoveddatoer

Studiestart

Primær fullføring (Faktiske)

Studiet fullført (Faktiske)

Datoer for studieregistrering

Først innsendt

Først innsendt som oppfylte QC-kriteriene

Først lagt ut (Anslag)

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

Siste oppdatering sendt inn som oppfylte QC-kriteriene

Sist bekreftet

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

Kliniske studier på Lungekreft

Kliniske studier på cetuximab

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Indonesia

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder