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

30 de outubro de 2012 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

242

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 2
Medicamento: 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.

Medicamento: 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

Medicamento: 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.
Comparador Ativo: 1
Medicamento: 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.

Medicamento: 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

Medicamento: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Select a regimen based on overall survival
Prazo: 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)
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Correlation of epidermal growth factor receptor polymorphisms and downstream biomarkers with response
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Southwest Oncology Group

Colaboradores

National Cancer Institute (NCI)

Investigadores

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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de julho de 2004

Conclusão Primária (Real)

1 de agosto de 2007

Conclusão do estudo (Real)

1 de julho de 2011

Datas de inscrição no estudo

Enviado pela primeira vez

10 de junho de 2004

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de junho de 2004

Primeira postagem (Estimativa)

11 de junho de 2004

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

1 de novembro de 2012

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de outubro de 2012

Última verificação

1 de outubro de 2012

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CDR0000370806
  • U10CA032102 (Concessão/Contrato do NIH dos EUA)
  • S0342 (Outro identificador: SWOG)

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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