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S9716: Combination Chemotherapy in Treating Patients With Merkel Cell Cancer

5. oktober 2012 oppdatert av: Southwest Oncology Group

A Phase II Trial of Cyclophosphamide, Methotrexate and 5-Fluorouracil (CMF) in Neuroendocrine Carcinoma of the Skin (Merkel Cell Carcinoma)

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.

PURPOSE: Phase II trial to study the effectiveness of combining cyclophosphamide, methotrexate, and fluorouracil in treating patients with Merkel cell cancer.

Studieoversikt

Status

Fullført

Forhold

Nevroendokrint karsinom i huden

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES: I. Investigate the ability of the Southwest Oncology Group Melanoma Committee to enroll patients with unresectable Merkel cell carcinoma that is local-regional or metastatic. II. Determine the overall survival rate and objective response rate of these patients after treatment with cyclophosphamide, methotrexate, and fluorouracil.

OUTLINE: Patients are stratified according to local-regional disease versus metastatic disease. Patients receive cyclophosphamide IV, methotrexate IV, and fluorouracil IV on day 1. Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicities. Patients are followed every 6 months for 2 years, then annually thereafter.

PROJECTED ACCRUAL: A total of 80 patients (40 patients per stratum) will be accrued for this study.

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, 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
  - 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
  - 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, 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
    - MBCCOP - LSU Medical Center
  - New Orleans, Louisiana, Forente stater, 70112
    - Veterans Affairs Medical Center - New Orleans
  - 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
  - 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 - 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
  - 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, 78284-7811
    - 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 proven unresectable Merkel cell carcinoma Local-regional OR Metastatic Bidimensionally measurable disease If all known sites previously irradiated, disease must be progressive CNS metastases allowed if not only site of measurable disease No pleural effusions or ascites

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception No other prior malignancy within 5 years except: Adequately treated basal cell or squamous cell skin cancer Adequately treated stage I or II cancer In situ cervical cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy or immunotherapy No concurrent immunotherapy Chemotherapy: No prior chemotherapy for metastatic disease At least 4 weeks since prior adjuvant chemotherapy No prior adjuvant cyclophosphamide, methotrexate, or fluorouracil No other concurrent chemotherapy Endocrine therapy: No concurrent hormone therapy Radiotherapy: See Disease Characteristics At least 14 days since prior radiotherapy Surgery: At least 2 weeks since prior surgery

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: Raymond A. Kempf, MD, University of Southern California

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 1998

Primær fullføring (Faktiske)

1. september 2001

Studiet fullført (Faktiske)

1. januar 2003

Datoer for studieregistrering

Først innsendt

1. november 1999

Først innsendt som oppfylte QC-kriteriene

23. juni 2004

Først lagt ut (Anslag)

24. juni 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

8. oktober 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. oktober 2012

Sist bekreftet

1. oktober 2012

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

CDR0000066606
U10CA032102 (U.S. NIH-stipend/kontrakt)
S9716 (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. .