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

30 ottobre 2012 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

242

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 2
Droga: 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.

Droga: 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

Droga: 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.
Comparatore attivo: 1
Droga: 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.

Droga: 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

Droga: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Select a regimen based on overall survival
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Correlation of epidermal growth factor receptor polymorphisms and downstream biomarkers with response
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Southwest Oncology Group

Collaboratori

National Cancer Institute (NCI)

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 luglio 2004

Completamento primario (Effettivo)

1 agosto 2007

Completamento dello studio (Effettivo)

1 luglio 2011

Date di iscrizione allo studio

Primo inviato

10 giugno 2004

Primo inviato che soddisfa i criteri di controllo qualità

10 giugno 2004

Primo Inserito (Stima)

11 giugno 2004

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

1 novembre 2012

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 ottobre 2012

Ultimo verificato

1 ottobre 2012

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CDR0000370806
  • U10CA032102 (Sovvenzione/contratto NIH degli Stati Uniti)
  • S0342 (Altro identificatore: SWOG)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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