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Panitumumab (Vectibix®) in Cutaneous Squamous Cell Carcinoma (SCC) (PASCE)

27. august 2010 opdateret af: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

An Open Label Multicentric Phase II Study of Panitumumab (Vectibix®) in Cutaneous Squamous Cell Carcinoma (SCC)

Squamous Cell Carcinoma (SCC) is one of the most common malignancies in caucasian population. The effect of the immune system on the development of skin tumors has been demonstrated in transplant patients taking immunosuppressive agents (65 fold risk increase). It has been reported that activation of EGFR and RAS signaling pathways play an important role in disease progression maybe through downregulation of the immune system.

The investigators want to treat unresectable SCC patients with an antibody against EGFR (Vectibix®, panitumumab). This antibody induces tumor regression in metastatic colorectal cancer and has been approved as single agent for this indication.

The investigators want to measure the response rate but also analyze the modification of expression profile of some key proteins involved or supposed to be involved in the signaling pathways of EGFR and in the regulation of the immune system. Chemokines such as CCL27 have been shown to play a critical role in the skin-associated immune response by regulating T cell homing. Pivarcsi et al have reported that downregulation of CCL27 is mediated by activation of EGFR/RAS/MAPK signaling pathways.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is an open-label, multicentric study of 17 patients with skin squamous cancer cell.

Eligible patients should not be suitable for immediate surgery. If they have only one tumor, it should be greater than 3 cm2 in order to allow multiple biopsies.

Patients will receive six infusions of Panitumumab 6 mg/kg every 2 weeks or until progression if earlier.

Patients will be assessed at baseline, at week 6 and then every 12 weeks till progression. In addition to clinical examination, evaluation tools will include photography and CT-scan, MRI or PET-scan.

Skin and tumor biopsies will be performed during first cycle at baseline and at days 2, 4, 8, 43, 85. Blood collections for translational research will be done during first cycle at baseline and at days 2, 4, 8,15, 43, 85. Blood collection for hematology and chemistry assessment will be done each 4weeks.

Patients presenting with a stable disease or a tumor response at week 12 will be eligible for maintenance cycles consisting in an infusion of panitumumab every 2 weeks till progression.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

17

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Belgien
      • Bruxelles, Belgien, 1200
      • Mont Godinne, Belgien, 5530
        • Rekruttering
        • Cliniques Universitaires UCL
        • Kontakt:
          • Kerger Joseph, MD, PhD
          • Telefonnummer: +32 81423328
      • Ottignies, Belgien, 1340
        • Rekruttering
        • Cliniques Saint-Pierre
        • Kontakt:
          • Duck Lionel, MD
          • Telefonnummer: +32 10414953

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

Inclusion criteria

  • Patient with histologically confirmed diagnosis of SCC.
  • Patient must not be candidate to direct curative surgery.
  • Tumor evaluation by photography with a ruler and CT-scan, MRI or PET-scan must be performed before enrollment.
  • Age ≥ 18 years.
  • Karnofsky Performance status (KPS) ≥70.

  • Normal laboratory values:

    • Platelet count ≥100x103/μL
    • Leucocyte count ≥ 3x103/μL
    • Hemoglobin ≥ 9 g/dL
    • ASAT and ALAT ≤ 2.5xUNL
    • Serum creatinine ≤1.5xUNL
    • Total bilirubin ≤ 1.5xUNL
    • Magnesium ≥ Lower Normal Limit (LLN)
    • Calcium ≥ Lower Normal Limit (LLN)
  • Patient should agree to perform biopsies and blood collections for translational research.
  • Signed informed consent from the patient or legal representative must be obtained.

Exclusion criteria

  • Clinically significant cardiovascular disease (including cardiac insufficiency NYHA grade III and IV, unstable angina, arrythmia, myocardial infarction, symptomatic congestive heart failure)in the past 12 months before enrollment.
  • History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
  • No prior chemotherapy.
  • Prior anti-EGFR therapy.
  • Radiation within four weeks prior to trial entry.
  • Subject pregnant or breastfeeding, or planning to become pregnant within 6 months after the end of treatment.
  • Subject (male or female) not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months after the end of treatment.
  • The patient has (or has had) previous or concomitant malignancies at other sites within last 5years, except effectively treated malignancy that is considered by the investigator highly likely to have been cured.

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: panitumumab
Patients will receive six infusions of panitumumab every 2 weeks for the first cycle.
Medicin: infusions of Panitumumab
Patients will receive six infusions of Panitumumab 6 mg/kg every 2 weeks or until progression if earlier.
Andre navne:
  • Vectibix®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Response Rate (ORR)
Tidsramme: via imaging every 12 weeks
To measure the efficacy of Panitumumab for SCC in terms of Overall Response Rate (ORR). Overall Response Rate (ORR) is defined as the sum of complete and partial tumour responses seen, divided by the total number of evaluable patients.
via imaging every 12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To assess the safety profile of panitumumab in SCC
Tidsramme: at each visit
Proportion of all adverse events will be reported. CTC scale 3.0 will be used with the exception of skin- or nail-related toxicities, which must be graded using CTC version 3.0 with modifications (Appendix E). Patients will be followed for safety until closure of study.
at each visit
Time to treatment failure (TTF)and Time to treatment progression TTP
Tidsramme: via imaging, every 12 weeks
Time to treatment failure (TTF) is defined as the time from date of first dose of study medication to first occurrence of any following event : documentation of objective tumor progression, toxicities requiring prematurely stop of treatment or death. TTF will be calculated according to the Kaplan-Meier technique. Time to Progression will also be calculated. Subjects without evidence of progression at the end of follow up will be considered as censored.
via imaging, every 12 weeks
To measure the duration of response.
Tidsramme: via imaging, every 12 weeks
Duration of overall response will be measured according RECIST guidelines version 1.1 Duration of response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study).
via imaging, every 12 weeks
To explore the gene expression profiles in SCC under panitumumab treatment (i.e CCL27, EGFR,…).
Tidsramme: Skin and tumor biopsies will be performed at baseline and at days 2, 4, 8, 43, 85. Blood will be collected at baseline and at days 2, 4, 8, 43, 85
Results will be presented as proportion of each expression type.
Skin and tumor biopsies will be performed at baseline and at days 2, 4, 8, 43, 85. Blood will be collected at baseline and at days 2, 4, 8, 43, 85

Samarbejdspartnere og efterforskere

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

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Samarbejdspartnere

Cliniques Universitaires UCL de Mont-Godinne, Dr Joseph Kerger
Cliniques Saint-Pierre Ottignies, Dr Lionel Duck

Efterforskere

  • Ledende efterforsker: Baurain Jean-Francois, Md,PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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. august 2010

Primær færdiggørelse (Forventet)

1. juli 2012

Studieafslutning (Forventet)

1. juli 2012

Datoer for studieregistrering

Først indsendt

21. maj 2010

Først indsendt, der opfyldte QC-kriterier

21. maj 2010

Først opslået (Skøn)

24. maj 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. august 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. august 2010

Sidst verificeret

1. august 2010

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Luc 09-002

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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