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

30 octobre 2012 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

242

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 2
Médicament: 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.

Médicament: 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

Médicament: 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.
Comparateur actif: 1
Médicament: 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.

Médicament: 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

Médicament: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Select a regimen based on overall survival
Délai: 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)
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Correlation of epidermal growth factor receptor polymorphisms and downstream biomarkers with response
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Southwest Oncology Group

Collaborateurs

National Cancer Institute (NCI)

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juillet 2004

Achèvement primaire (Réel)

1 août 2007

Achèvement de l'étude (Réel)

1 juillet 2011

Dates d'inscription aux études

Première soumission

10 juin 2004

Première soumission répondant aux critères de contrôle qualité

10 juin 2004

Première publication (Estimation)

11 juin 2004

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

1 novembre 2012

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 octobre 2012

Dernière vérification

1 octobre 2012

Plus d'information

Termes liés à cette étude

Mots clés

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Autres numéros d'identification d'étude

  • CDR0000370806
  • U10CA032102 (Subvention/contrat des NIH des États-Unis)
  • S0342 (Autre identifiant: SWOG)

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