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S9714: Paclitaxel in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

20. juli 2012 oppdatert av: Southwest Oncology Group

Phase II Trial of Paclitaxel by 96-Hour Infusion in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy with paclitaxel in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES: I. Assess survival, progression-free survival and response rate of patients with bronchioloalveolar carcinoma receiving paclitaxel. II. Evaluate toxic effects of paclitaxel in 96 hour continuous infusion patients.

OUTLINE: Patients receive 6 cycles of paclitaxel by IV continuous infusion over 96 hours. Before cycle 4, restaging is performed. If disease progression is witnessed, patients are removed from the study. If a stable, partial, or complete response is observed, patients receive the total of 6 cycles. Three weeks after the last cycle, final restaging is performed. Patients are followed every 3 months while on treatment and every 6 months thereafter, unless more frequent follow-up is clinically recommended.

PROJECTED ACCRUAL: 50 patients will be enrolled. The accrual rate is estimated at 25 per year.

Studietype

Intervensjonell

Registrering (Faktiske)

60

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Alabama
      • Mobile, Alabama, Forente stater, 36688
        • MBCCOP - University of South Alabama
    • Arizona
      • Phoenix, Arizona, Forente stater, 85006-2726
        • CCOP - Greater Phoenix
      • Phoenix, Arizona, Forente stater, 85012
        • Veterans Affairs Medical Center - Phoenix (Hayden)
      • Tucson, Arizona, Forente stater, 85724
        • Arizona Cancer Center
      • Tucson, Arizona, Forente stater, 85723
        • Veterans Affairs Medical Center - Tucson
    • Arkansas
      • Little Rock, Arkansas, Forente stater, 72205
        • University of Arkansas for Medical Sciences
      • Little Rock, Arkansas, Forente stater, 72205
        • Veterans Affairs Medical Center - Little Rock (McClellan)
    • California
      • Duarte, California, Forente stater, 91010
        • Beckman Research Institute, City of Hope
      • Long Beach, California, Forente stater, 90822
        • Veterans Affairs Medical Center - Long Beach
      • Los Angeles, California, Forente stater, 90033-0800
        • USC/Norris Comprehensive Cancer Center
      • Los Angeles, California, Forente stater, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Martinez, California, Forente stater, 94553
        • Veterans Affairs Outpatient Clinic - Martinez
      • Oakland, California, Forente stater, 94609-3305
        • CCOP - Bay Area Tumor Institute
      • Sacramento, California, Forente stater, 95817
        • University of California Davis Medical Center
      • San Francisco, California, Forente stater, 94115-0128
        • UCSF Cancer Center and Cancer Research Institute
      • Santa Rosa, California, Forente stater, 95403
        • CCOP - Santa Rosa Memorial Hospital
      • Travis Air Force Base, California, Forente stater, 94535
        • David Grant Medical Center
    • Colorado
      • Denver, Colorado, Forente stater, 80220
        • Veterans Affairs Medical Center - Denver
      • Denver, Colorado, Forente stater, 80262
        • University of Colorado Cancer Center
    • Georgia
      • Atlanta, Georgia, Forente stater, 30342-1701
        • CCOP - Atlanta Regional
      • Fort Gordon, Georgia, Forente stater, 30905-5650
        • Dwight David Eisenhower Army Medical Center
    • Hawaii
      • Honolulu, Hawaii, Forente stater, 96859-5000
        • Tripler Army Medical Center
      • Honolulu, Hawaii, Forente stater, 96813
        • Cancer Research Center of Hawaii
    • Illinois
      • Hines, Illinois, Forente stater, 60141
        • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
      • Maywood, Illinois, Forente stater, 60153
        • Loyola University Medical Center
      • Springfield, Illinois, Forente stater, 62526
        • CCOP - Central Illinois
    • Kansas
      • Kansas City, Kansas, Forente stater, 66160-7357
        • University of Kansas Medical Center
      • Wichita, Kansas, Forente stater, 67214-3882
        • CCOP - Wichita
      • Wichita, Kansas, Forente stater, 67218
        • Veterans Affairs Medical Center - Wichita
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40511-1093
        • Veterans Affairs Medical Center - Lexington
      • Lexington, Kentucky, Forente stater, 40536-0084
        • Albert B. Chandler Medical Center, University of Kentucky
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70112
        • Tulane University School of Medicine
      • New Orleans, Louisiana, Forente stater, 70112
        • MBCCOP - LSU Medical Center
      • New Orleans, Louisiana, Forente stater, 70112
        • Veterans Affairs Medical Center - New Orleans
      • Shreveport, Louisiana, Forente stater, 71130
        • Veterans Affairs Medical Center - Shreveport
      • Shreveport, Louisiana, Forente stater, 71130-3932
        • Louisiana State University Hospital - Shreveport
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02118
        • Boston Medical Center
      • Jamaica Plain, Massachusetts, Forente stater, 02130
        • Veterans Affairs Medical Center - Boston (Jamaica Plain)
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109-0752
        • University of Michigan Comprehensive Cancer Center
      • Ann Arbor, Michigan, Forente stater, 48105
        • Veterans Affairs Medical Center - Ann Arbor
      • Detroit, Michigan, Forente stater, 48201
        • Barbara Ann Karmanos Cancer Institute
      • Detroit, Michigan, Forente stater, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, Forente stater, 48201-1932
        • Veterans Affairs Medical Center - Detroit
      • Grand Rapids, Michigan, Forente stater, 49503
        • CCOP - Grand Rapids Clinical Oncology Program
      • Southfield, Michigan, Forente stater, 48075-9975
        • Providence Hospital - Southfield
    • Mississippi
      • Biloxi, Mississippi, Forente stater, 39531-2410
        • Veterans Affairs Medical Center - Biloxi
      • Jackson, Mississippi, Forente stater, 39216-4505
        • University of Mississippi Medical Center
      • Jackson, Mississippi, Forente stater, 39216
        • Veterans Affairs Medical Center - Jackson
      • Keesler AFB, Mississippi, Forente stater, 39534-2576
        • Keesler Medical Center - Keesler AFB
    • Missouri
      • Kansas City, Missouri, Forente stater, 64128
        • Veterans Affairs Medical Center - Kansas City
      • Kansas City, Missouri, Forente stater, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, Forente stater, 63110-0250
        • St. Louis University Health Sciences Center
      • Saint Louis, Missouri, Forente stater, 63141
        • CCOP - St. Louis-Cape Girardeau
      • Springfield, Missouri, Forente stater, 65807
        • CCOP - Ozarks Regional
    • Montana
      • Billings, Montana, Forente stater, 59101
        • CCOP - Montana Cancer Consortium
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87108-5138
        • Veterans Affairs Medical Center - Albuquerque
      • Albuquerque, New Mexico, Forente stater, 87131
        • University of New Mexico Cancer Research & Treatment Center
    • New York
      • Brooklyn, New York, Forente stater, 11209
        • Veterans Affairs Medical Center - Brooklyn
      • New York, New York, Forente stater, 10032
        • Herbert Irving Comprehensive Cancer Center
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45219
        • Barrett Cancer Center, The University Hospital
      • Cincinnati, Ohio, Forente stater, 45220-2288
        • Veterans Affairs Medical Center - Cincinnati
      • Cleveland, Ohio, Forente stater, 44195
        • Cleveland Clinic Cancer Center
      • Columbus, Ohio, Forente stater, 43206
        • CCOP - Columbus
      • Dayton, Ohio, Forente stater, 45428
        • Veterans Affairs Medical Center - Dayton
      • Kettering, Ohio, Forente stater, 45429
        • CCOP - Dayton
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73104
        • Oklahoma Medical Research Foundation
      • Oklahoma City, Oklahoma, Forente stater, 73104
        • Veterans Affairs Medical Center - Oklahoma City
    • Oregon
      • Portland, Oregon, Forente stater, 97201-3098
        • Oregon Cancer Center at Oregon Health Sciences University
      • Portland, Oregon, Forente stater, 97207
        • Veterans Affairs Medical Center - Portland
      • Portland, Oregon, Forente stater, 97213
        • CCOP - Columbia River Program
    • South Carolina
      • Greenville, South Carolina, Forente stater, 29615
        • CCOP - Greenville
      • Spartanburg, South Carolina, Forente stater, 29303
        • CCOP - Upstate Carolina
    • Texas
      • Fort Sam Houston, Texas, Forente stater, 78234
        • Brooke Army Medical Center
      • Galveston, Texas, Forente stater, 77555-1329
        • University of Texas Medical Branch
      • Lubbock, Texas, Forente stater, 79423
        • Texas Tech University Health Science Center
      • San Antonio, Texas, Forente stater, 78284
        • Veterans Affairs Medical Center - San Antonio (Murphy)
      • San Antonio, Texas, Forente stater, 78284
        • University of Texas Health Science Center at San Antonio
      • Temple, Texas, Forente stater, 76504
        • Veterans Affairs Medical Center - Temple
      • Temple, Texas, Forente stater, 76508
        • CCOP - Scott and White Hospital
    • Utah
      • Salt Lake City, Utah, Forente stater, 84132
        • Huntsman Cancer Institute
      • Salt Lake City, Utah, Forente stater, 84148
        • Veterans Affairs Medical Center - Salt Lake City
    • Washington
      • Seattle, Washington, Forente stater, 98101
        • CCOP - Virginia Mason Research Center
      • Seattle, Washington, Forente stater, 98108
        • Veterans Affairs Medical Center - Seattle
      • Seattle, Washington, Forente stater, 98104
        • Swedish Hospital Tumor Institute
      • Tacoma, Washington, Forente stater, 98405-0986
        • CCOP - Northwest

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

DISEASE CHARACTERISTICS: Histologically proven Stage IIIB or IV bronchioloalveolar non-small cell lung carcinoma -incompletely resected or unresectable -tumors may be multifocal or diffuse -measurable or evaluable disease required No prior brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: SWOG 0-2 Life Expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than institutional upper limit of normal (ULN) SGOT no greater than 2 times ULN Renal: Creatinine no greater than institutional ULN OR creatinine clearance at least 50 mL/min Other: Not pregnant or nursing Effective contraceptive method used while on study No prior malignancies allowed, except: basal or squamous cell skin cancer in situ cervical cancer Stage I or II cancer which is in remission Any cancer from which patients have been disease free for 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for lung cancer Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiation therapy (including palliative radiotherapy) Surgery: Prior surgery is allowed

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Southwest Oncology Group

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Studiestol: Ralph B. Vance, MD, University of Mississippi Cancer Clinic

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 1997

Primær fullføring (Faktiske)

1. januar 2004

Studiet fullført (Faktiske)

1. januar 2007

Datoer for studieregistrering

Først innsendt

1. november 1999

Først innsendt som oppfylte QC-kriteriene

23. august 2004

Først lagt ut (Anslag)

24. august 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

24. juli 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. juli 2012

Sist bekreftet

1. juli 2012

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CDR0000065476
  • U10CA032102 (U.S. NIH-stipend/kontrakt)
  • S9714 (Annen identifikator: SWOG)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Lungekreft

Kliniske studier på paklitaksel

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Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

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CROs in Equatorial Guinea

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Legemiddelintervensjoner

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