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Gemcitabine With or Without Capecitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

25. juni 2013 opdateret af: Cancer Research UK

A Phase III Multicenter Randomized Clinical Trial Comparing Gemcitabine Alone Or In Combination With Capecitabine For The Treatment Of Patients With Advanced Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if gemcitabine is more effective with or without capecitabine in treating pancreatic cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or without capecitabine in treating patients who have locally advanced or metastatic pancreatic cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

  • Compare the 1-year survival rate of patients with locally advanced or metastatic pancreatic cancer treated with gemcitabine with or without capecitabine.
  • Compare the median and 2-year survival rates and the objective response rates of patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is an randomized, open-label, multicenter study. Patients are stratified according to disease stage (locally advanced vs metastatic) and performance status (0 and 1 vs 2). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive gemcitabine IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43 during the first course. After a 1-week rest period, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Subsequent courses repeat every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 3 months for 1 year, and then annually thereafter.

Patients are followed every 3 months.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 508 patients (254 per treatment arm) will be accrued for this study.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

508

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Det Forenede Kongerige
    • England
      • Bath, England, Det Forenede Kongerige, BA1 3NG
        • Royal United Hospital
      • Bournemouth, England, Det Forenede Kongerige, BH7 7DW
        • Royal Bournemouth Hospital
      • Bristol, England, Det Forenede Kongerige, BS2 8ED
        • Bristol Haematology and Oncology Centre
      • Cambridge, England, Det Forenede Kongerige, CB2 2QQ
        • Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
      • Derby, England, Det Forenede Kongerige, DE1 2QY
        • Derbyshire Royal Infirmary
      • Exeter, England, Det Forenede Kongerige, EX2 5DW
        • Royal Devon and Exeter Hospital
      • Ipswich, England, Det Forenede Kongerige, IP4 5PD
        • Ipswich Hospital NHS Trust
      • King's Lynn, England, Det Forenede Kongerige, PE30 4ET
        • Queen Elizabeth Hospital
      • Leeds, England, Det Forenede Kongerige, LS16 6QB
        • Cookridge Hospital at Leeds Teaching Hospital NHS Trust
      • Leicester, England, Det Forenede Kongerige, LE1 5WW
        • Leicester Royal Infirmary
      • Lincoln, England, Det Forenede Kongerige, LN2 5QY
        • Lincoln County Hospital
      • Liverpool, England, Det Forenede Kongerige, L69 3GA
        • Royal Liverpool University Hospital
      • Liverpool, England, Det Forenede Kongerige, L3 9TA
        • Cancer Research UK Liverpool Cancer Trials Unit
      • London, England, Det Forenede Kongerige, SE1 7EH
        • St. Thomas' Hospital
      • Manchester, England, Det Forenede Kongerige, M20 4BX
        • Christie Hospital NHS Trust
      • Merseyside, England, Det Forenede Kongerige, CH63 4JY
        • Clatterbridge Centre for Oncology NHS Trust
      • Middlesbrough, Cleveland, England, Det Forenede Kongerige, TS4 3BW
        • James Cook University Hospital at South Tees Hospitals NHS Trust
      • Newcastle-Upon-Tyne, England, Det Forenede Kongerige, NE4 6BE
        • Northern Centre for Cancer Treatment at Newcastle General Hospital
      • Norwich, England, Det Forenede Kongerige, NR4 7UY
        • Norfolk and Norwich University Hospital
      • Plymouth, England, Det Forenede Kongerige, PL6 8DH
        • Derriford Hospital
      • Poole Dorset, England, Det Forenede Kongerige, BH15 2JB
        • Poole Hospital NHS Trust
      • Prescot Merseyside, England, Det Forenede Kongerige, L35 5DR
        • Whiston Hospital
      • Preston, England, Det Forenede Kongerige, PR2 9HT
        • Royal Preston Hospital
      • Salisbury, England, Det Forenede Kongerige, SP2 8BJ
        • Salisbury District Hospital
      • Southampton, England, Det Forenede Kongerige, SO14 0YG
        • Royal South Hants Hospital
      • Stoke-On-Trent, England, Det Forenede Kongerige, ST4 7LN
        • University Hospital of North Staffordshire
      • Sutton, England, Det Forenede Kongerige, SM2 5PT
        • Royal Marsden NHS Foundation Trust - Surrey
      • Warrington, England, Det Forenede Kongerige, WA5 1QG
        • Warrington Hospital NHS Trust
    • Scotland
      • Aberdeen, Scotland, Det Forenede Kongerige, AB25 2ZN
        • Aberdeen Royal Infirmary
    • Wales
      • Swansea, Wales, Det Forenede Kongerige, SA2 8QA
        • Singleton Hospital of the Swansea NHS Trust

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 or cytologically confirmed ductal adenocarcinoma of the pancreas

    • Locally advanced or metastatic disease not amenable to curative surgical resection
    • Macroscopic residual disease after prior resection with histological confirmation is allowed
  • Unidimensionally measurable disease
  • No intracerebral metastases or meningeal carcinomatosis

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • WHO 0-2

Life expectancy:

  • More than 3 months

Hematopoietic:

  • WBC greater than 3,000/mm3
  • Neutrophil count greater than 1,500/mm3
  • Platelet count greater than 100,000/mm3

Hepatic:

  • Bilirubin less than 2 mg/dL

Renal:

  • Creatinine less than 2 mg/dL
  • Creatinine clearance greater than 50 mL/min

Cardiovascular:

  • No New York Heart Association class III or IV heart disease
  • No uncontrolled angina pectoris

Other:

  • No other prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No other concurrent uncontrolled medical condition
  • No other medical or psychiatric condition that would preclude study
  • No known hypersensitivity to fluorouracil
  • No dihydropyrimidine dehydrogenase deficiency
  • No known malabsorption syndromes
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy (including preoperative or adjuvant) for this disease
  • No other concurrent cytotoxic chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy (including preoperative or adjuvant) for this disease

Surgery:

  • See Disease Characteristics

Other:

  • No prior investigational drugs (including preoperative or adjuvant) for this disease
  • No other concurrent investigational drugs
  • No concurrent dipyridamole or allopurinol
  • No concurrent sorivudine or sorivudine analogs (e.g., brivudine) (capecitabine arm only)

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: Randomiseret
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Overlevelse ved 1 år

Sekundære resultatmål

Resultatmål
Toksicitet
Livskvalitet
Objektiv svarprocent
Median survival rate
Survival rate at 2 years

Samarbejdspartnere og efterforskere

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

Sponsor

Cancer Research UK

Efterforskere

  • Emily Owen, Cancer Research UK

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. april 2002

Studieafslutning (Faktiske)

1. maj 2007

Datoer for studieregistrering

Først indsendt

8. marts 2002

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. juni 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juni 2013

Sidst verificeret

1. april 2007

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CRUK-GEM-CAP
  • CDR0000069263 (Registry Identifier: PDQ (Physician Data Query))
  • EU-20116
  • ISRCTN11513444

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 .

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Poland

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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