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Combination Chemotherapy With or Without Cetuximab Before and After Surgery in Treating Patients With Resectable Liver Metastases Caused By Colorectal Cancer

22. januar 2013 oppdatert av: University of Southampton

A Prospective Randomised Open Label Trial of Oxaliplatin/Fluoropyrimidine Versus Oxaliplatin/Fluoropyrimidine Plus Cetuximab Pre and Post Operatively in Patients With Resectable Colorectal Liver Metastasis Requiring Chemotherapy

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy together with monoclonal antibodies before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether combination chemotherapy is more effective with or without cetuximab in treating liver metastases caused by colorectal cancer.

PURPOSE: This randomized phase III trial is studying combination chemotherapy to compare how well it works when given with or without cetuximab before and after surgery in treating patients with resectable liver metastases caused by colorectal cancer.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES:

Primary

  • Compare progression-free survival of patients with resectable colorectal liver metastases treated with neoadjuvant and adjuvant combination chemotherapy with vs without cetuximab.

Secondary

  • Compare the overall survival of patients treated with these regimens.
  • Compare the quality of life of patients treated with these regimens.
  • Compare the cost effectiveness of these regimens in these patients.

OUTLINE: This is a prospective, randomized, multicenter, open-label study. Patients are stratified according to participating center and assigned chemotherapy regimen. Patients are randomized to 1 of 2 treatment arms.

  • Neoadjuvant therapy:

    • Arm I: Patients receive 1 of the following chemotherapy regimens:

      • OxMdG: Patients receive leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
      • CAPOX: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

    • Arm II: Patients receive 1 of the following regimens:

      • OxMdG + cetuximab: Patients receive cetuximab IV over 1-2 hours on day 1 and OxMdG chemotherapy as in arm I. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
      • CAPOX + cetuximab: Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and CAPOX chemotherapy as in arm I. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
  • Surgery: Beginning 2-6 weeks after completion of chemotherapy, patients in both arms undergo liver resection.

  • Adjuvant therapy: Beginning 4-8 weeks after completion of surgery, patients receive treatment (OxMdG or CAPOX with or without cetuximab) as in arm I or II of neoadjuvant therapy.

    • Arm I: Treatment with OxMdG repeats every 2 weeks for up to 6 courses and treatment with CAPOX repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
    • Arm II: Treatment with OxMdG + cetuximab repeats every 2 weeks for up to 6 courses and treatment with CAPOX + cetuximab repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 12 weeks during chemotherapy, at completion of study treatment, every 3 months for 1 year, and then every 6 months thereafter.

Cost per life year and per quality-adjusted life year is assessed at baseline, every 12 weeks during treatment, and then at 3, 5, and 10 years.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

Studietype

Intervensjonell

Registrering (Forventet)

340

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Storbritannia
    • England
      • Basildon, England, Storbritannia, SS16 5NL
        • Rekruttering
        • Basildon University Hospital
        • Ta kontakt med:
          • Pauline Leonard, MD
          • Telefonnummer: 44-1702-435-555
      • Basingstoke, England, Storbritannia, RG24 9NA
        • Rekruttering
        • Basingstoke and North Hampshire NHS Foundation Trust
        • Ta kontakt med:
          • Charlotte Rees, MD
          • Telefonnummer: 44-125-631-4793
      • Bournemouth, England, Storbritannia, BH7 7DW
        • Rekruttering
        • Royal Bournemouth Hospital
        • Ta kontakt med:
      • Cambridge, England, Storbritannia, CB2 0QQ
      • Guildford, England, Storbritannia, GU2 7XX
        • Rekruttering
        • St. Luke's Cancer Centre at Royal Surrey County Hospital
        • Ta kontakt med:
          • Sharadah Essapen, MD
          • Telefonnummer: 44-1483-571-122
      • Liverpool, England, Storbritannia, L9 7AL
        • Rekruttering
        • Aintree University Hospital
        • Ta kontakt med:
      • Liverpool, England, Storbritannia, L9 7AL
        • Rekruttering
        • Royal Liverpool University Hospital
        • Ta kontakt med:
          • Paula Ghaneh, MD
      • London, England, Storbritannia, SW3 6JJ
        • Rekruttering
        • Royal Marsden - London
        • Ta kontakt med:
          • David Cunningham, MD
          • Telefonnummer: 44-20-8661-3156
      • London, England, Storbritannia, EC1A 7BE
        • Rekruttering
        • Saint Bartholomew's Hospital
      • London, England, Storbritannia, W6 8RF
        • Rekruttering
        • Charing Cross Hospital
        • Ta kontakt med:
      • London, England, Storbritannia, NW3 2PF
        • Rekruttering
        • UCL Cancer Institute
        • Ta kontakt med:
      • Merseyside, England, Storbritannia, CH63 4JY
        • Rekruttering
        • Clatterbridge Centre For Oncology
      • Newport, England, Storbritannia, PO30 5TG
        • Rekruttering
        • St. Mary's Hospital
        • Ta kontakt med:
          • Christopher Baughan, MD
          • Telefonnummer: 44-1983-524-081
      • Nottingham, England, Storbritannia, NG5 1PB
        • Rekruttering
        • Cancer Research Centre at Weston Park Hospital
        • Ta kontakt med:
          • J. Hornbuckle, MD
          • Telefonnummer: 44-115-969-1169 ext. 47599
      • Poole Dorset, England, Storbritannia, BH15 2JB
        • Rekruttering
        • Dorset Cancer Centre
        • Ta kontakt med:
          • Tamas Hickish, MD
          • Telefonnummer: 44-1202-442-532
      • Salisbury, England, Storbritannia, SP2 8BJ
        • Rekruttering
        • Salisbury District Hospital
      • Southampton, England, Storbritannia, SO16 6YD
        • Rekruttering
        • Southampton General Hospital
        • Ta kontakt med:
      • Sutton, England, Storbritannia, SM2 5PT
        • Rekruttering
        • Royal Marsden - Surrey
      • Westcliff-On-Sea, England, Storbritannia, SS0 0RY
        • Rekruttering
        • Southend University Hospital NHS Foundation Trust
        • Ta kontakt med:
          • Pauline Leonard, MD
          • Telefonnummer: 44-1702-435-555
      • Worthing, England, Storbritannia, BN11 2DH
        • Rekruttering
        • Worthing Hospital
        • Ta kontakt med:
          • Andrew Webb, MD
          • Telefonnummer: 44-1903-205-111
    • Wales
      • Cardiff, Wales, Storbritannia, CF14 2TL
        • Rekruttering
        • Velindre Cancer Center at Velindre Hospital
        • Ta kontakt med:
          • Timothy Maughan, MD
          • Telefonnummer: 44-2920-316-904
      • Cardiff, Wales, Storbritannia, CF14 4XW
        • Rekruttering
        • University Hospital of Wales
        • Ta kontakt med:
          • Timothy Maughan, MD
          • Telefonnummer: 44-2920-316-904

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 radiologically confirmed primary adenocarcinoma of the colon or rectum

    • Advanced and/or metastatic disease NOTE: *Liver metastases should not be biopsied

  • Must have potentially resectable liver metastases present, as defined by any of the following:

    • Metachronous metastases AND complete resection of the primary tumor without gross or microscopic evidence of residual disease (R0)
    • Synchronous metastases AND R0 resection of the primary tumor > 1 month before study entry
    • Synchronous metastases with sufficient evidence (e.g., by CT scan or diagnostic laparoscopy) that both the primary tumor and the liver metastases can be completely resected during the same procedure and resection of primary tumor can be delayed for 3-4 months
    • Suboptimally resectable disease (i.e., potentially resectable disease with compromise of the resection margins)
  • No detectable extrahepatic tumor that cannot be completely resected
  • Unidimensionally measurable disease
  • No brain metastases

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • WBC ≥ 4,000/mm³
  • ANC ≥ 1,500/mm³
  • Platelet count > 150,000/mm³
  • Bilirubin ≤ 1.25 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 5 times ULN
  • AST or ALT ≤ 3 times ULN
  • Creatinine clearance > 50 mL/min OR glomerular filtration rate > 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
  • No psychiatric or neurological condition that would preclude study compliance
  • No partial or complete bowel obstruction
  • No preexisting neuropathy > grade 1
  • No other prior or concurrent malignant disease that, in the opinion of the investigator, would preclude study treatment
  • No concurrent severe uncontrolled medical illness (including poorly-controlled angina or myocardial infarction within the past 3 months) that would preclude study treatment
  • No known hypersensitivity reaction to any of the components of the study drugs

PRIOR CONCURRENT THERAPY:

  • No prior systemic chemotherapy for metastatic disease
  • More than 6 months since prior adjuvant chemotherapy comprising fluorouracil, leucovorin calcium, capecitabine, or irinotecan hydrochloride
  • More than 1 month since prior rectal chemoradiotherapy comprising fluorouracil and leucovorin calcium
  • No concurrent contraindicated medication

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: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: OxMdG / IrMdG chemotherapy
OxMdG / IrMdG chemotherapy for 12 weeks Followed by surgery OxMdG / IrMdG chemotherapy for 12 weeks
Legemiddel: fluorouracil
Legemiddel: leukovorin kalsium
Fremgangsmåte: adjuvant terapi
Fremgangsmåte: neoadjuvant terapi
Legemiddel: oksaliplatin
Fremgangsmåte: livskvalitetsvurdering
Legemiddel: capecitabin
Annen: studie av sosioøkonomiske og demografiske variabler
Eksperimentell: OxMdG / IrMdG chemotherapy with cetuximab
OxMdG / IrMdG chemotherapy with cetuximab for 12 weeks Followed by Surgery OxMdG / IrMdG chemotherapy with cetuximab for 12 weeks
Legemiddel: fluorouracil
Legemiddel: leukovorin kalsium
Fremgangsmåte: adjuvant terapi
Fremgangsmåte: neoadjuvant terapi
Legemiddel: oksaliplatin
Fremgangsmåte: livskvalitetsvurdering
Legemiddel: capecitabin
Annen: studie av sosioøkonomiske og demografiske variabler
Biologisk: cetuximab

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Progression-free survival
Tidsramme: end of study
end of study

Sekundære resultatmål

Resultatmål
Tidsramme
Samlet overlevelse
Tidsramme: slutten av studiet
slutten av studiet
Response rate before surgery as assessed by RECIST criteria
Tidsramme: end of study
end of study
Pathological resection status
Tidsramme: end of study
end of study
Toxicity
Tidsramme: end of study
end of study
Quality of life as assessed by the EQ-5D, EORTC QLQ-C30, and EORTC QLQ-LMC21
Tidsramme: end of study
end of study
Cost effectiveness
Tidsramme: end of study
end of study
Safety
Tidsramme: end of study
end of study

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Southampton

Samarbeidspartnere

University Hospital Southampton NHS Foundation Trust

Etterforskere

  • Studiestol: John N. Primrose, MD, University Hospital Southampton NHS Foundation Trust

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 2007

Primær fullføring (Forventet)

1. desember 2014

Datoer for studieregistrering

Først innsendt

4. juni 2007

Først innsendt som oppfylte QC-kriteriene

4. juni 2007

Først lagt ut (Anslag)

5. juni 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

23. januar 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. januar 2013

Sist bekreftet

1. april 2008

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CDR0000549541
  • USCTU-4351
  • USCTU-EPOC
  • EUDRACT-2006-003121-82
  • ISRCTN22944367
  • EU-20732

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. .

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