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Gemcitabine Plus Docetaxel in Treating Patients With Unresectable or Metastatic Liver Cancer

5. december 2016 opdateret af: Alliance for Clinical Trials in Oncology

Phase II Trial of Gemcitabine and Docetaxel in Patients With Unresectable or Metastatic Hepatocellular 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 chemotherapy drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of gemcitabine plus docetaxel in treating patients who have unresectable or metastatic liver cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

  • Assess the six-month overall survival of patients with unresectable or metastatic hepatocellular carcinoma treated with gemcitabine and docetaxel.
  • Determine tumor response and time to progression in this patient population treated with this regimen.
  • Determine the toxicity of this regimen in these patients.
  • Assess the pharmacokinetics of docetaxel in patients treated with this regimen.

OUTLINE: Patients receive docetaxel IV over 15-60 minutes and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks. Patients achieving complete response after 2 courses of therapy receive 2 additional courses of therapy. Patients with stable disease or partial response continue therapy until disease progression.

Patients are followed every 3 months for 1 year and then every 6 months for 4 years.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

25

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre
  • Forenede Stater
    • Arizona
      • Scottsdale, Arizona, Forenede Stater, 85259-5404
        • CCOP - Scottsdale Oncology Program
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32224
        • Mayo Clinic
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30342-1701
        • CCOP - Atlanta Regional
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96813
        • MBCCOP - Hawaii
    • Illinois
      • Peoria, Illinois, Forenede Stater, 61602
        • CCOP - Illinois Oncology Research Association
      • Urbana, Illinois, Forenede Stater, 61801
        • CCOP - Carle Cancer Center
    • Iowa
      • Cedar Rapids, Iowa, Forenede Stater, 52403-1206
        • CCOP - Cedar Rapids Oncology Project
      • Des Moines, Iowa, Forenede Stater, 50309-1016
        • CCOP - Iowa Oncology Research Association
      • Sioux City, Iowa, Forenede Stater, 51101-1733
        • Siouxland Hematology-Oncology
    • Kansas
      • Wichita, Kansas, Forenede Stater, 67214-3882
        • CCOP - Wichita
    • Minnesota
      • Duluth, Minnesota, Forenede Stater, 55805
        • CCOP - Duluth
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic Cancer Center
    • North Dakota
      • Bismarck, North Dakota, Forenede Stater, 58501-5505
        • Medcenter One Health System
    • Ohio
      • Toledo, Ohio, Forenede Stater, 43623-3456
        • CCOP - Toledo Community Hospital
    • Pennsylvania
      • Danville, Pennsylvania, Forenede Stater, 17822-2001
        • CCOP - Geisinger Clinic and Medical Center
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57104
        • CCOP - Sioux Community Cancer Consortium

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically confirmed unresectable or metastatic hepatocellular carcinoma not amenable to combined radiotherapy and chemotherapy or orthotopic liver transplantation
  • Measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension as at least 20 mm
  • Evidence of disease progression by serial imaging or biochemical evidence of a rising alpha-fetoprotein by serial testing

  • No history of brain or other CNS metastases not amenable to local therapy

    • Locally treatable CNS lesions (i.e., lesions treatable with surgery or radiosurgery) allowed if no evidence of CNS progression for at least 4 weeks after completion of therapy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10.0 g/dL

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST no greater than 2.5 times ULN

Renal

  • Creatinine no greater than 1.5 times ULN

Other

  • No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior hypersensitivity reaction to taxanes or other drugs formulated with polysorbate 80
  • No grade 2 or greater peripheral neuropathy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 4 weeks since prior biologic therapy or immunotherapy
  • No concurrent immunotherapy

Chemotherapy

  • See Disease Characteristics
  • Prior chemotherapy (excluding gemcitabine) for radiosensitization allowed
  • At least 4 weeks since prior chemotherapy
  • At least 6 months since prior chemoembolization
  • No prior chemotherapy for metastatic disease
  • No other concurrent chemotherapy

Endocrine therapy

  • At least 4 weeks since prior hormonal therapy

Radiotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • No prior radiotherapy to 25% or more of bone marrow
  • No concurrent radiotherapy

Surgery

  • See Disease Characteristics

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: docetaxel + gemcitabine

Patients receive docetaxel IV over 15-60 minutes and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks. Patients achieving complete response after 2 courses of therapy receive 2 additional courses of therapy. Patients with stable disease or partial response continue therapy until disease progression.

Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
Medicin: docetaxel
Medicin: gemcitabin hydrochlorid

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
six-month overall survival
Tidsramme: at 6 months
at 6 months

Sekundære resultatmål

Resultatmål
Tidsramme
tid til progression
Tidsramme: Op til 5 år
Op til 5 år
tumor response
Tidsramme: Up to 5 years
Up to 5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Alliance for Clinical Trials in Oncology

Samarbejdspartnere

National Cancer Institute (NCI)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2001

Primær færdiggørelse (Faktiske)

1. maj 2004

Studieafslutning (Faktiske)

1. april 2008

Datoer for studieregistrering

Først indsendt

5. juli 2000

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. december 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. december 2016

Sidst verificeret

1. december 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NCCTG-N0041
  • NCI-2012-02349 (Registry Identifier: CTRP (Clinical Trials Reporting System))
  • CDR0000068019 (Registry Identifier: PDQ (Physician Data Query))

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Leverkræft

Kliniske forsøg med docetaxel

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Guinea

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner