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S9914: Combination Chemotherapy Plus Filgrastim in Untreated Extensive-Stage Small Cell Lung Cancer

12. februar 2013 opdateret af: Southwest Oncology Group

Phase II Trial of Paclitaxel, Carboplatin and Topotecan With G-CSF in Untreated Patients With Extensive Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus filgrastim in treating patients who have previously untreated extensive-stage small cell lung cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES: I. Assess the survival and response rate of patients with previously untreated extensive stage small cell lung cancer treated with paclitaxel, carboplatin, topotecan, and filgrastim (G-CSF). II. Determine the side effects and toxicity of this regimen in these patients.

OUTLINE: Patients receive topotecan IV over 30 minutes on days 1-4 and paclitaxel IV over 1 hour followed by carboplatin IV over 1 hour prior to topotecan on day 4. Patients receive filgrastim (G-CSF) subcutaneously once daily beginning on day 5 and continuing until blood counts recover. G-CSF must be discontinued at least 24 hours prior to beginning each subsequent course of chemotherapy. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study over 18 months.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

88

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Mobile, Alabama, Forenede Stater, 36652
        • MBCCOP - Gulf Coast
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85006-2726
        • CCOP - Greater Phoenix
      • Phoenix, Arizona, Forenede Stater, 85012
        • Veterans Affairs Medical Center - Phoenix (Hayden)
      • Tucson, Arizona, Forenede Stater, 85724
        • Arizona Cancer Center
      • Tucson, Arizona, Forenede Stater, 85723
        • Veterans Affairs Medical Center - Tucson
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • University of Arkansas for Medical Sciences
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Veterans Affairs Medical Center - Little Rock (McClellan)
    • California
      • Long Beach, California, Forenede Stater, 90822
        • Veterans Affairs Medical Center - Long Beach
      • Los Angeles, California, Forenede Stater, 90033-0800
        • USC/Norris Comprehensive Cancer Center
      • Los Angeles, California, Forenede Stater, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Los Angeles, California, Forenede Stater, 91010
        • Beckman Research Institute, City of Hope
      • Martinez, California, Forenede Stater, 94553
        • Veterans Affairs Outpatient Clinic - Martinez
      • Oakland, California, Forenede Stater, 94609-3305
        • CCOP - Bay Area Tumor Institute
      • Orange, California, Forenede Stater, 92868
        • Chao Family Comprehensive Cancer Center
      • Sacramento, California, Forenede Stater, 95817
        • University of California Davis Medical Center
      • Santa Rosa, California, Forenede Stater, 95403
        • CCOP - Santa Rosa Memorial Hospital
      • Travis Air Force Base, California, Forenede Stater, 94535
        • David Grant Medical Center
    • Colorado
      • Denver, Colorado, Forenede Stater, 80220
        • Veterans Affairs Medical Center - Denver
      • Denver, Colorado, Forenede Stater, 80262
        • University of Colorado Cancer Center
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30342-1701
        • CCOP - Atlanta Regional
      • Fort Gordon, Georgia, Forenede Stater, 30905-5650
        • Dwight David Eisenhower Army Medical Center
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96813
        • Cancer Research Center of Hawaii
    • Illinois
      • Decatur, Illinois, Forenede Stater, 62526
        • CCOP - Central Illinois
      • Hines, Illinois, Forenede Stater, 60141
        • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
      • Maywood, Illinois, Forenede Stater, 60153
        • Loyola University Medical Center
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160-7357
        • University of Kansas Medical Center
      • Wichita, Kansas, Forenede Stater, 67214-3882
        • CCOP - Wichita
      • Wichita, Kansas, Forenede Stater, 67218
        • Veterans Affairs Medical Center - Wichita
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40511-1093
        • Veterans Affairs Medical Center - Lexington
      • Lexington, Kentucky, Forenede Stater, 40536-0084
        • Albert B. Chandler Medical Center, University of Kentucky
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Tulane University School of Medicine
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Veterans Affairs Medical Center - New Orleans
      • New Orleans, Louisiana, Forenede Stater, 70112
        • MBCCOP - LSU Health Sciences Center
      • Shreveport, Louisiana, Forenede Stater, 71130-3932
        • Louisiana State University Health Sciences Center - Shreveport
      • Shreveport, Louisiana, Forenede Stater, 71130
        • Veterans Affairs Medical Center - Shreveport
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02118
        • Boston Medical Center
      • Boston, Massachusetts, Forenede Stater, 02135-2997
        • St. Elizabeth's Medical Center
      • Jamaica Plain, Massachusetts, Forenede Stater, 02130
        • Veterans Affairs Medical Center - Boston (Jamaica Plain)
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109-0752
        • University of Michigan Comprehensive Cancer Center
      • Ann Arbor, Michigan, Forenede Stater, 48105
        • Veterans Affairs Medical Center - Ann Arbor
      • Detroit, Michigan, Forenede Stater, 48201
        • Barbara Ann Karmanos Cancer Institute
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, Forenede Stater, 48201-1932
        • Veterans Affairs Medical Center - Detroit
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • CCOP - Grand Rapids Clinical Oncology Program
      • Southfield, Michigan, Forenede Stater, 48075-9975
        • Providence Hospital - Southfield
    • Mississippi
      • Biloxi, Mississippi, Forenede Stater, 39531-2410
        • Veterans Affairs Medical Center - Biloxi
      • Jackson, Mississippi, Forenede Stater, 39216-4505
        • University of Mississippi Medical Center
      • Jackson, Mississippi, Forenede Stater, 39216
        • Veterans Affairs Medical Center - Jackson
      • Keesler AFB, Mississippi, Forenede Stater, 39534-2576
        • Keesler Medical Center - Keesler AFB
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64128
        • Veterans Affairs Medical Center - Kansas City
      • Kansas City, Missouri, Forenede Stater, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, Forenede Stater, 63141
        • CCOP - St. Louis-Cape Girardeau
      • Springfield, Missouri, Forenede Stater, 65807
        • CCOP - Cancer Research for the Ozarks
    • Montana
      • Billings, Montana, Forenede Stater, 59101
        • CCOP - Montana Cancer Consortium
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87108-5138
        • Veterans Affairs Medical Center - Albuquerque
      • Albuquerque, New Mexico, Forenede Stater, 87131
        • MBCCOP - University of New Mexico HSC
    • New York
      • New York, New York, Forenede Stater, 10032
        • Herbert Irving Comprehensive Cancer Center
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke Comprehensive Cancer Center
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45219
        • Barrett Cancer Center, The University Hospital
      • Cincinnati, Ohio, Forenede Stater, 45220-2288
        • Veterans Affairs Medical Center - Cincinnati
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Columbus, Ohio, Forenede Stater, 43206
        • CCOP - Columbus
      • Dayton, Ohio, Forenede Stater, 45428
        • Veterans Affairs Medical Center - Dayton
      • Kettering, Ohio, Forenede Stater, 45429
        • CCOP - Dayton
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Oklahoma Medical Research Foundation
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Veterans Affairs Medical Center - Oklahoma City
    • Oregon
      • Portland, Oregon, Forenede Stater, 97207
        • Veterans Affairs Medical Center - Portland
      • Portland, Oregon, Forenede Stater, 97213
        • CCOP - Columbia River Program
      • Portland, Oregon, Forenede Stater, 97201-3098
        • Oregon Cancer Institute at Oregon Health and Science University
    • South Carolina
      • Greenville, South Carolina, Forenede Stater, 29615
        • CCOP - Greenville
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • CCOP - Upstate Carolina
    • Texas
      • Dallas, Texas, Forenede Stater, 75235-9154
        • Simmons Cancer Center - Dallas
      • Fort Sam Houston, Texas, Forenede Stater, 78234
        • Brooke Army Medical Center
      • Galveston, Texas, Forenede Stater, 77555-0209
        • University of Texas Medical Branch
      • Lubbock, Texas, Forenede Stater, 79423
        • Texas Tech University Health Science Center
      • San Antonio, Texas, Forenede Stater, 78284-7811
        • University of Texas Health Science Center at San Antonio
      • San Antonio, Texas, Forenede Stater, 78284
        • Veterans Affairs Medical Center - San Antonio (Murphy)
      • Temple, Texas, Forenede Stater, 76504
        • Veterans Affairs Medical Center - Temple
      • Temple, Texas, Forenede Stater, 76508
        • CCOP - Scott and White Hospital
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84132
        • Huntsman Cancer Institute
      • Salt Lake City, Utah, Forenede Stater, 84148
        • Veterans Affairs Medical Center - Salt Lake City
    • Washington
      • Seattle, Washington, Forenede Stater, 98101
        • CCOP - Virginia Mason Research Center
      • Seattle, Washington, Forenede Stater, 98104
        • Swedish Cancer Institute
      • Seattle, Washington, Forenede Stater, 98108
        • Veterans Affairs Medical Center - Seattle
      • Tacoma, Washington, Forenede Stater, 98405-0986
        • CCOP - Northwest

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS: Histologically or cytologically proven, previously untreated extensive stage small cell lung cancer (SCLC) Brain metastases allowed if: Asymptomatic OR Previously treated with radiotherapy and/or surgery Measurable or evaluable disease outside the area of prior surgical resection or a new lesion must be present

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) SGOT or SGPT no greater than 2.5 times ULN Renal: Creatinine no greater than ULN Creatinine clearance at least 50 mL/min Other: Not pregnant or nursing Fertile patients must use effective contraception 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 any stage I or II cancer that is in complete remission

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior systemic biologic therapy for SCLC Chemotherapy: No prior systemic chemotherapy for SCLC Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy for SCLC Surgery: See Disease Characteristics At least 2 weeks since prior thoracic or other major surgery and recovered

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Southwest Oncology Group

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Studiestol: Frank Dunphy, MD, Duke Cancer Institute

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 1999

Primær færdiggørelse (Faktiske)

1. marts 2004

Studieafslutning (Faktiske)

1. november 2008

Datoer for studieregistrering

Først indsendt

10. december 1999

Først indsendt, der opfyldte QC-kriterier

9. april 2004

Først opslået (Skøn)

12. april 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

15. februar 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. februar 2013

Sidst verificeret

1. februar 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000067367
  • U10CA032102 (U.S. NIH-bevilling/kontrakt)
  • S9914 (Anden identifikator: SWOG)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Lungekræft

Kliniske forsøg med carboplatin

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Argentina

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner