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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 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Werkelijk)

242

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 2
Geneesmiddel: 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.

Geneesmiddel: 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

Geneesmiddel: 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.
Actieve vergelijker: 1
Geneesmiddel: 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.

Geneesmiddel: 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

Geneesmiddel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Select a regimen based on overall survival
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Correlation of epidermal growth factor receptor polymorphisms and downstream biomarkers with response
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Southwest Oncology Group

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juli 2004

Primaire voltooiing (Werkelijk)

1 augustus 2007

Studie voltooiing (Werkelijk)

1 juli 2011

Studieregistratiedata

Eerst ingediend

10 juni 2004

Eerst ingediend dat voldeed aan de QC-criteria

10 juni 2004

Eerst geplaatst (Schatting)

11 juni 2004

Updates van studierecords

Laatste update geplaatst (Schatting)

1 november 2012

Laatste update ingediend die voldeed aan QC-criteria

30 oktober 2012

Laatst geverifieerd

1 oktober 2012

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CDR0000370806
  • U10CA032102 (Subsidie/contract van de Amerikaanse NIH)
  • S0342 (Andere identificatie: SWOG)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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