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S0030: Capecitabine in Treating Older Patients W/Metastatic or Recurrent Colorectal Cancer That Cannot Be Surgically Removed

2. januar 2013 oppdatert av: Southwest Oncology Group

Protocol For Assessment Of Capecitabine For Advanced Colorectal Cancer In Patients Aged 70 Years And Older (And In A Cohort Of Patients Younger Than 60 Years)

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 capecitabine in treating older patients who have metastatic or recurrent colorectal cancer that cannot be surgically removed.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES:

  • Determine the feasibility of enrolling patients aged 70 and over with unresectable metastatic or recurrent colorectal cancer to a structured phase II study.
  • Determine the anticancer efficacy of capecitabine, in terms of objective response rate (confirmed and unconfirmed, complete and partial responses) and 2-year survival, in these patients.
  • Determine the toxicity and tolerability of this drug in these patients.
  • Determine the feasibility of using standardized self-report measures of comorbidity, depression, and functional status of patients treated with this drug.
  • Determine the clinical pharmacology of this drug in these patients.
  • Determine whether patients under 60 years of age treated with this drug have clinical pharmacologic parameters similar to those reported in the literature.

OUTLINE: This is a multicenter study. Patients are stratified according to age (70 and over vs 18 to 59).

Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 80 patients (60 patients aged 70 and over, 20 patients aged 18 to 59) will be accrued for this study.

Studietype

Intervensjonell

Registrering (Faktiske)

29

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, 36607
        • 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
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
      • Little Rock, Arkansas, Forente stater, 72205
        • Veterans Affairs Medical Center - Little Rock
    • California
      • Duarte, California, Forente stater, 91010-3000
        • City of Hope Comprehensive Cancer Center
      • Loma Linda, California, Forente stater, 92357
        • Veterans Affairs Medical Center - Loma Linda (Pettis)
      • Los Angeles, California, Forente stater, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Los Angeles, California, Forente stater, 90033
        • USC/Norris Comprehensive Cancer Center and Hospital
      • 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 at University of California Irvine Cancer Center
      • Sacramento, California, Forente stater, 95817
        • University of California Davis Cancer Center
      • Santa Rosa, California, Forente stater, 95403
        • CCOP - Santa Rosa Memorial Hospital
    • Colorado
      • Aurora, Colorado, Forente stater, 80010
        • University of Colorado Cancer Center at University of Colorado Health Sciences Center
      • Denver, Colorado, Forente stater, 80220
        • Veterans Affairs Medical Center - Denver
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 20060
        • MBCCOP - Howard University Cancer Center
    • Florida
      • Tampa, Florida, Forente stater, 33612
        • Veterans Affairs Medical Center - Tampa (Haley)
    • Georgia
      • Atlanta, Georgia, Forente stater, 30342-1701
        • CCOP - Atlanta Regional
    • Hawaii
      • Honolulu, Hawaii, Forente stater, 96813
        • MBCCOP - Hawaii
    • Illinois
      • Chicago, Illinois, Forente stater, 60612
        • Veterans Affairs Medical Center - Chicago (Westside Hospital)
      • Chicago, Illinois, Forente stater, 60612
        • MBCCOP - University of Illinois at Chicago
      • Decatur, Illinois, Forente stater, 62526
        • CCOP - Central Illinois
      • Hines, Illinois, Forente stater, 60141
        • Veterans Affairs Medical Center - Hines
      • Maywood, Illinois, Forente stater, 60153-5500
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
    • Kansas
      • Kansas City, Kansas, Forente stater, 66160-7353
        • Kansas Masonic Cancer Research Institute at the 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, 40502-2236
        • Veterans Affairs Medical Center - Lexington
      • Lexington, Kentucky, Forente stater, 40536-0084
        • Markey Cancer Center at University of Kentucky Chandler Medical Center
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70112
        • Veterans Affairs Medical Center - New Orleans
      • New Orleans, Louisiana, Forente stater, 70112
        • MBCCOP - LSU Health Sciences Center
      • New Orleans, Louisiana, Forente stater, 70112
        • Tulane Cancer Center at Tulane University Hospital and Clinic
      • Shreveport, Louisiana, Forente stater, 71130-3932
        • Louisiana State University Health Sciences Center - Shreveport
      • Shreveport, Louisiana, Forente stater, 71101-4295
        • Veterans Affairs Medical Center - Shreveport
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02118
        • Cancer Research Center at Boston Medical Center
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Ann Arbor, Michigan, Forente stater, 48109-0948
        • University of Michigan Comprehensive Cancer Center
      • Detroit, Michigan, Forente stater, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Detroit, Michigan, Forente stater, 48201-1932
        • Veterans Affairs Medical Center - Detroit
      • Detroit, Michigan, Forente stater, 48202
        • Josephine Ford Cancer Center at Henry Ford Health System
      • Grand Rapids, Michigan, Forente stater, 49503
        • CCOP - Grand Rapids
      • Royal Oak, Michigan, Forente stater, 48073-6769
        • CCOP - Beaumont
      • Southfield, Michigan, Forente stater, 48075
        • Providence Cancer Institute at Providence Hospital - Southfield
    • Mississippi
      • 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, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, Forente stater, 63141
        • CCOP - St. Louis-Cape Girardeau
      • Saint Louis, Missouri, Forente stater, 63110
        • St. Louis University Hospital Cancer 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
      • New York, New York, Forente stater, 10016
        • NYU School of Medicine's Kaplan Comprehensive Cancer Center
      • 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
      • Goldsboro, North Carolina, Forente stater, 27534-9479
        • CCOP - Southeast Cancer Control Consortium
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45220-2288
        • Veterans Affairs Medical Center - Cincinnati
      • Cincinnati, Ohio, Forente stater, 45267-0501
        • Charles M. Barrett Cancer Center at University Hospital
      • Cleveland, Ohio, Forente stater, 44195-9001
        • Cleveland Clinic Taussig Cancer Center
      • Columbus, Ohio, Forente stater, 43206
        • CCOP - Columbus
      • Dayton, Ohio, Forente stater, 45429
        • CCOP - Dayton
      • Dayton, Ohio, Forente stater, 45428-1002
        • Veterans Affairs Medical Center - Dayton
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73104
        • Oklahoma University Medical center
    • 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
        • Cancer Institute at Oregon Health and Science University
    • 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, 38104
        • Veterans Affairs Medical Center - Memphis
      • Memphis, Tennessee, Forente stater, 38104
        • University of Tennessee Cancer Institute at Methodist Central Hospital
    • Texas
      • Amarillo, Texas, Forente stater, 79106
        • Harrington Cancer Center
      • Amarillo, Texas, Forente stater, 79106
        • Veterans Affairs Medical Center - Amarillo
      • 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, 77030-4095
        • University of Texas - MD Anderson Cancer Center
      • 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
    • 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, 98109
        • Puget Sound Oncology Consortium
      • 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 metastatic or recurrent colorectal cancer not amenable to surgical resection
  • Measurable disease
  • No known brain metastases by MRI or CT scan

PATIENT CHARACTERISTICS:

Age

  • 70 and over OR
  • 18 to 59

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute granulocyte count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • SGOT (serum glutamate oxaloacetate transaminase) or SGPT (serum glutamate pyruvate transaminase) no greater than 2 times ULN

Renal

  • Creatinine no greater than 2 times ULN
  • Creatinine clearance greater than 50 mL/min

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • HIV negative
  • No known seizure disorder
  • No other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, adequately treated stage I or II cancer currently in complete remission, or any other cancer for which the patient has been disease free for 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for advanced cancer
  • Prior adjuvant chemotherapy allowed provided recurrence occurred more than 1 year after the last treatment

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • At least 4 weeks since prior sorivudine or brivudine
  • No concurrent sorivudine or brivudine

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: Capecitabine
Capecitabine 1,000 mg/m^2/dose (2,000 mg/m^2/day) BID, PO, Days 1-14 of 21 day cycle.
Legemiddel: capecitabine
1,000 mg/m^2/dose (2,000 mg/m^2/day) BID, PO, on Days 1-14 of 21 day cycle
Andre navn:
  • NSC-712807

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Feasibility of enrolling patients aged 70 years or older to a Phase II trial including pharmacokinetic sampling
Tidsramme: Registration
Registration

Sekundære resultatmål

Resultatmål
Tidsramme
Giftighet
Tidsramme: 3 år
3 år
Efficacy of capecitabine for management of advanced colorectal cancer patients aged 70 years or older based on objective response rate and 2 year survival
Tidsramme: 2 years
2 years
Assess parameters of clinical pharmacology of capecitabine in patients aged 70 years or older including half life value(s), AUC (area under curve) and steady state levels
Tidsramme: 3 years
3 years
Assess whether patients under 60 years have clinical pharmacologic parameters similar to those reported in the literature
Tidsramme: 3 years
3 years
Explore, at a preliminary level, the feasibility of studying genetic polymorphisms and gene expression levels of enzymes involved in drug metabolism and resistance to capecitabine
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)

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. februar 2003

Primær fullføring (Faktiske)

1. juni 2007

Studiet fullført (Faktiske)

1. juni 2007

Datoer for studieregistrering

Først innsendt

12. november 2002

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

  • CDR0000258049
  • U10CA032102 (U.S. NIH-stipend/kontrakt)
  • S0030 (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 Tykktarmskreft

Kliniske studier på capecitabine

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Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

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Forhold

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Legemiddelintervensjoner

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