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S9926 Temozolomide in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumors

2. januar 2013 oppdatert av: Southwest Oncology Group

Phase II Study of Temozolomide in Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST)

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 temozolomide in treating patients who have unresectable or metastatic gastrointestinal stromal tumors.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES:

  • Determine the complete and partial response (confirmed and unconfirmed) in patients with unresectable or metastatic gastrointestinal stromal tumors treated with temozolomide.
  • Determine the qualitative or quantitative toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving a confirmed complete response (CR) receive 2 additional courses after a confirmed CR.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 13-27 months.

Studietype

Intervensjonell

Registrering (Faktiske)

25

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 - Gulf Coast
    • Arizona
      • Phoenix, Arizona, Forente stater, 85006-2726
        • CCOP - Western Regional, Arizona
      • Phoenix, Arizona, Forente stater, 85012
        • Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
      • Tucson, Arizona, Forente stater, 85723
        • Veterans Affairs Medical Center - Tucson
      • Tucson, Arizona, Forente stater, 85724
        • Arizona Cancer Center at University of Arizona Health Sciences Center
    • 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
        • City of Hope Comprehensive Cancer Center
      • Long Beach, California, Forente stater, 90822
        • Veterans Affairs Medical Center - Long Beach
      • Los Angeles, California, Forente stater, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Los Angeles, California, Forente stater, 90033-0804
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Los Angeles, California, Forente stater, 90073
        • Veterans Affairs Medical Center - West Los Angeles
      • 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 Cancer Center
      • San Francisco, California, Forente stater, 94143-0128
        • UCSF Comprehensive Cancer 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, 80010
        • University of Colorado Cancer Center at University of Colorado Health Sciences Center
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 20060
        • MBCCOP - Howard University 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
        • MBCCOP - Hawaii
      • Honolulu, Hawaii, Forente stater, 96813-2424
        • Cancer Research Center of Hawaii
    • Illinois
      • Chicago, Illinois, Forente stater, 60612-7323
        • MBCCOP - University of Illinois at Chicago
      • Chicago, Illinois, Forente stater, 60612
        • Veterans Affairs Medical Center - Chicago (Westside Hospital)
      • 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, 60153-5500
        • Loyola University Medical Center
    • Kansas
      • Kansas City, Kansas, Forente stater, 66160-7353
        • 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, 40536-0084
        • Albert B. Chandler Medical Center, University of Kentucky
      • Lexington, Kentucky, Forente stater, 40502-2236
        • Veterans Affairs Medical Center - Lexington
    • 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
      • Jamaica Plain, Massachusetts, Forente stater, 02130
        • Veterans Affairs Medical Center - Boston (Jamaica Plain)
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48105
        • Veterans Affairs Medical Center - Ann Arbor
      • Ann Arbor, Michigan, Forente stater, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Ann Arbor, Michigan, Forente stater, 48109-0912
        • University Of Michigan Comprehensive Cancer Center
      • Detroit, Michigan, Forente stater, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, Forente stater, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Detroit, Michigan, Forente stater, 48201-1932
        • Veterans Affairs Medical Center - Detroit
      • Grand Rapids, Michigan, Forente stater, 49503
        • CCOP - Grand Rapids
      • Royal Oak, Michigan, Forente stater, 48073-6769
        • CCOP - Beaumont
      • Southfield, Michigan, Forente stater, 48075-9975
        • Providence Hospital - Southfield
    • Minnesota
      • Duluth, Minnesota, Forente stater, 55805
        • CCOP - Duluth
    • 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
    • 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
      • Saint Louis, Missouri, Forente stater, 63110
        • St. Louis University Health Sciences Center
      • 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
      • Albany, New York, Forente stater, 12208
        • Veterans Affairs Medical Center - Albany
      • New York, New York, Forente stater, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University
      • Rochester, New York, Forente stater, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
    • North Carolina
      • Winston-Salem, North Carolina, Forente stater, 27104-4241
        • CCOP - Southeast Cancer Control Consortium
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45220-2288
        • Veterans Affairs Medical Center - Cincinnati
      • Cincinnati, Ohio, Forente stater, 45267-0501
        • Barrett Cancer Center
      • Cleveland, Ohio, Forente stater, 44195-9001
        • Cleveland Clinic Taussig Cancer Center
      • Columbus, Ohio, Forente stater, 43206
        • CCOP - Columbus
      • Dayton, Ohio, Forente stater, 45428
        • Veterans Affairs Medical Center - Dayton
      • Dayton, Ohio, Forente stater, 45429
        • CCOP - Dayton
      • Toledo, Ohio, Forente stater, 43623-3456
        • CCOP - Toledo Community Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73104
        • University of Oklahoma Health Sciences Center
      • 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, 97225
        • CCOP - Columbia River Oncology Program
      • Portland, Oregon, Forente stater, 97201-3098
        • Oregon Cancer Institute
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425
        • Hollings Cancer Center at Medical University of South Carolina
      • Charleston, South Carolina, Forente stater, 29401-5799
        • Veterans Affairs Medical Center - Charleston
      • Greenville, South Carolina, Forente stater, 29615
        • CCOP - Greenville
      • Spartanburg, South Carolina, Forente stater, 29303
        • CCOP - Upstate Carolina
    • Tennessee
      • Memphis, Tennessee, Forente stater, 38103
        • University of Tennessee Cancer Institute
      • Memphis, Tennessee, Forente stater, 38104
        • Danville Radiation Therapy Center
    • Texas
      • Amarillo, Texas, Forente stater, 79106
        • Harrington Cancer Center
      • Amarillo, Texas, Forente stater, 79106
        • Veterans Affairs Medical Center - Amarillo
      • Dallas, Texas, Forente stater, 75216
        • Veterans Affairs Medical Center - Dallas
      • Fort Sam Houston, Texas, Forente stater, 78234-6200
        • Brooke Army Medical Center
      • Galveston, Texas, Forente stater, 77555-0565
        • University of Texas Medical Branch
      • Houston, Texas, Forente stater, 77030
        • Veterans Affairs Medical Center - Houston
      • San Antonio, Texas, Forente stater, 78229-3900
        • University of Texas Health Science Center at San Antonio
      • San Antonio, Texas, Forente stater, 78229
        • 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, 84148
        • Veterans Affairs Medical Center - Salt Lake City
      • Salt Lake City, Utah, Forente stater, 84112-5550
        • Huntsman Cancer Institute
    • Vermont
      • Burlington, Vermont, Forente stater, 05401
        • Fletcher Allen Health Care - University Health Center Campus
    • Virginia
      • Richmond, Virginia, Forente stater, 23298-0037
        • MBCCOP - Massey Cancer Center
    • 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 Cancer Institute at Swedish Medical Center - First Hill Campus
      • Tacoma, Washington, Forente stater, 98431-5000
        • Madigan Army Medical Center
      • 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 confirmed unresectable or metastatic gastrointestinal stromal tumor (GIST)

    • Primary (gastrointestinal or intra-abdominal origin) tumor

  • At least 1 measurable lesion by x-ray, CT, MRI, ultrasound, or physical examination

    • If lesions within prior radiation port are used as target lesions for response assessment, those lesions must have demonstrated clear progression after completion of radiotherapy
  • No uterine or retroperitoneal sarcomas or non-intra-abdominal leiomyosarcomas

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC (white blood count) at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 2 times upper limit of normal (ULN)

Renal:

  • Creatinine no greater than 1.5 times ULN

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No medical or psychological conditions that would preclude study participation
  • No major infection requiring systemic antibiotics
  • No uncontrolled bacterial, viral, or fungal infection

  • No other prior malignancy within the past 5 years except:

    • Adequately treated basal cell or squamous cell skin cancer
    • Adequately treated stage I or II cancer in complete remission
    • Carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 30 days since prior biologic therapy
  • Prior imatinib mesylate as adjuvant therapy or for metastatic disease allowed

Chemotherapy:

  • No prior chemotherapy for GIST
  • At least 30 days since other prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • No prior radiotherapy for GIST
  • No concurrent radiotherapy for GIST
  • Concurrent palliative radiotherapy for painful metastases (encompassing a total portal of no greater than 5 x 5 cm) allowed

Surgery:

  • See Disease Characteristics
  • At least 4 weeks since prior major surgery and recovered

Other:

  • At least 30 days since prior investigational drugs

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)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Temozolomide
200 mg/m^2/day, PO, on Days 1-5 of each 28 day cycle.
Legemiddel: temozolomide
200 mg/m^2/day, PO, on Days 1-5 of each 28 day cycle.
Andre navn:
  • NSC-362856

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Assess response (confirmed & unconfirmed, complete & partial response)
Tidsramme: 3 years
3 years

Sekundære resultatmål

Resultatmål
Tidsramme
Toxicities
Tidsramme: 3 years
3 years

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: Mark M. Zalupski, MD, University of Michigan Rogel Cancer Center

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. april 2000

Primær fullføring (Faktiske)

1. oktober 2005

Studiet fullført (Faktiske)

1. oktober 2005

Datoer for studieregistrering

Først innsendt

2. mai 2000

Først innsendt som oppfylte QC-kriteriene

26. januar 2003

Først lagt ut (Anslag)

27. januar 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

3. januar 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. januar 2013

Sist bekreftet

1. januar 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CDR0000067710
  • U10CA032102 (U.S. NIH-stipend/kontrakt)
  • S9926 (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. .

Abonnere