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

12. februar 2013 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Lungekreft

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

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, 36652
    - MBCCOP - Gulf Coast
- 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
  - 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
  - Los Angeles, California, Forente stater, 91010
    - Beckman Research Institute, City of Hope
  - Martinez, California, Forente stater, 94553
    - Veterans Affairs Outpatient Clinic - Martinez
  - Oakland, California, Forente stater, 94609-3305
    - CCOP - Bay Area Tumor Institute
  - Orange, California, Forente stater, 92868
    - Chao Family Comprehensive Cancer Center
  - Sacramento, California, Forente stater, 95817
    - University of California Davis Medical Center
  - 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, 96813
    - Cancer Research Center of Hawaii
- Illinois
  - Decatur, Illinois, Forente stater, 62526
    - CCOP - Central Illinois
  - Hines, Illinois, Forente stater, 60141
    - Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
  - Maywood, Illinois, Forente stater, 60153
    - Loyola University Medical Center
- 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
    - Veterans Affairs Medical Center - New Orleans
  - New Orleans, Louisiana, Forente stater, 70112
    - MBCCOP - LSU Health Sciences Center
  - Shreveport, Louisiana, Forente stater, 71130-3932
    - Louisiana State University Health Sciences Center - Shreveport
  - Shreveport, Louisiana, Forente stater, 71130
    - Veterans Affairs Medical Center - Shreveport
- Massachusetts
  - Boston, Massachusetts, Forente stater, 02118
    - Boston Medical Center
  - Boston, Massachusetts, Forente stater, 02135-2997
    - St. Elizabeth's 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, 63141
    - CCOP - St. Louis-Cape Girardeau
  - Springfield, Missouri, Forente stater, 65807
    - CCOP - Cancer Research for the Ozarks
- 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
    - MBCCOP - University of New Mexico HSC
- New York
  - New York, New York, Forente stater, 10032
    - Herbert Irving Comprehensive Cancer Center
- North Carolina
  - Durham, North Carolina, Forente stater, 27710
    - Duke 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 Taussig 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, 97207
    - Veterans Affairs Medical Center - Portland
  - Portland, Oregon, Forente stater, 97213
    - CCOP - Columbia River Program
  - Portland, Oregon, Forente stater, 97201-3098
    - Oregon Cancer Institute at Oregon Health and Science University
- South Carolina
  - Greenville, South Carolina, Forente stater, 29615
    - CCOP - Greenville
  - Spartanburg, South Carolina, Forente stater, 29303
    - CCOP - Upstate Carolina
- Texas
  - Dallas, Texas, Forente stater, 75235-9154
    - Simmons Cancer Center - Dallas
  - Fort Sam Houston, Texas, Forente stater, 78234
    - Brooke Army Medical Center
  - Galveston, Texas, Forente stater, 77555-0209
    - University of Texas Medical Branch
  - Lubbock, Texas, Forente stater, 79423
    - Texas Tech University Health Science Center
  - San Antonio, Texas, Forente stater, 78284-7811
    - University of Texas Health Science Center at San Antonio
  - San Antonio, Texas, Forente stater, 78284
    - Veterans Affairs Medical Center - San Antonio (Murphy)
  - 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, 98104
    - Swedish Cancer Institute
  - Seattle, Washington, Forente stater, 98108
    - Veterans Affairs Medical Center - Seattle
  - 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 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

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: Frank Dunphy, MD, Duke Cancer Institute

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

Hesketh PJ, McCoy J, Dunphy FR 2nd, Bearden JD 3rd, Weiss GR, Giguere JK, Atkins JN, Dakhil SR, Kelly K, Crowley JJ, Gandara DR. Phase II trial of paclitaxel, carboplatin, and topotecan with G-CSF support in previously untreated patients with extensive stage small cell lung cancer: Southwest Oncology Group 9914. J Thorac Oncol. 2006 Nov;1(9):991-5.
Dunphy F, Hesketh P, Chansky K, et al.: Southwest Oncology Group trial (SWOG) 9914: phase II trial of paclitaxel, carboplatin and topotecan (PCT) in untreated patients (pts) with extensive small cell lung cancer (SCLC). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1184, 2002.

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. oktober 1999

Primær fullføring (Faktiske)

1. mars 2004

Studiet fullført (Faktiske)

1. november 2008

Datoer for studieregistrering

Først innsendt

10. desember 1999

Først innsendt som oppfylte QC-kriteriene

9. april 2004

Først lagt ut (Anslag)

12. april 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

15. februar 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. februar 2013

Sist bekreftet

1. februar 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

småcellet lungekreft i omfattende stadium

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

CDR0000067367
U10CA032102 (U.S. NIH-stipend/kontrakt)
S9914 (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. .