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

27 agosto 2010 aggiornato da: 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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

17

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Belgio
      • Bruxelles, Belgio, 1200
      • Mont Godinne, Belgio, 5530
        • Reclutamento
        • Cliniques Universitaires UCL
        • Contatto:
          • Kerger Joseph, MD, PhD
          • Numero di telefono: +32 81423328
      • Ottignies, Belgio, 1340
        • Reclutamento
        • Cliniques Saint-Pierre
        • Contatto:
          • Duck Lionel, MD
          • Numero di telefono: +32 10414953

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: panitumumab
Patients will receive six infusions of panitumumab every 2 weeks for the first cycle.
Droga: infusions of Panitumumab
Patients will receive six infusions of Panitumumab 6 mg/kg every 2 weeks or until progression if earlier.
Altri nomi:
  • Vectibix®

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Response Rate (ORR)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
To assess the safety profile of panitumumab in SCC
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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,…).
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Collaboratori

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

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 agosto 2010

Completamento primario (Anticipato)

1 luglio 2012

Completamento dello studio (Anticipato)

1 luglio 2012

Date di iscrizione allo studio

Primo inviato

21 maggio 2010

Primo inviato che soddisfa i criteri di controllo qualità

21 maggio 2010

Primo Inserito (Stima)

24 maggio 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

30 agosto 2010

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 agosto 2010

Ultimo verificato

1 agosto 2010

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Luc 09-002

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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