Clinical Trial: Treatment of Unresecable and/or Metastatic Merkel Cell Carcinoma by Somatostatine Analogues

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Traitement Des Carcinomes à Cellules de Merkel inopérables et/ou métastatiques Par Analogue de la Somatostatine - Etude Nationale Multicentrique Mono-bras de Phase II.

Brief Summary:

The purpose of this trial is to evaluate the efficacy of lanreotide on locally evolving and/or metastatic MCC in a national prospective multicentre phase II study (centres belonging to the skin cancer task force of the French Society of Dermatology namely "Groupe de Cancérologie Cutanée de la Société Française de Dermatologie"). This one-arm study, for which the primary endpoint is overall response to lanreotide, will follow an A'Hern plan in one step (A'Hern RP. Sample size tables for exact single-stage phase II designs. Stat Med 2001, 20:859-66) with main evaluation at 12 weeks on a population of 35 patients. The investigators make assumption that a 40% success rate at 3 months would be desirable, but if it was 20% or less the treatment would be unacceptable. It gives a trial size of 35 patients with a cut-off of 12 patients. Over 12 patients lanreotide will be considered as effective.

The lanreotide treatment (Somatuline LP 120 mg injected subcutaneously every 28 days) will be provided by IPSEN Pharma laboratory. An ancillary immunohistochemistry study on somatostatine receptors 2,3,5, dopamine receptors 1,2 and polyomavirus MCPyV will bring new data on this neuroendocrine tumour and potentially provide new therapeutic perspectives.

The results of this study may :

  • determine whether somatostatin analogues may help to treat locally advanced and/or metastatic MCC;
  • address whether there is a correlation between positive SPECT-CT (octreoscan) assessment and therapeutic response to lanreotide;
  • evaluate the place of TEP-CT and SPECT-CT for MCC evaluation/staging;
  • evaluate in future studies, with the ancillary

    Detailed Summary:

    The efficacy will be considered as success if patient have a positive response to lanreotide.

    Primary criterion Positive response at 3 months will be defined according to the RECIST 1.1 criteria (clinical and TDM evaluation will be done at 3 months): complete response (CR) or partial response (PR) or stable disease (SD) at 3 months.

    Secondary Objectives:

    • Assessment of the primary criterion at M6, M9, M12, M18 and M24
    • Description of the overall survival and time to progression
    • Assessment of the efficacy of the following radiological exams for staging the disease: SPECT-CT and TEP-CT
    • Description of the correlation of SPECT-CT results (positivity or negativity) and response to treatment, and the correlation of TEP-CT results and response to treatment
    • Description of the safety and tolerability of lanreotide in this study

    Population and Methods

    Experimental plan French national prospective multicentre phase II one-arm study. This one-arm study, for which the primary endpoint is overall response to lanreotide, will follow an A'Hern plan in one step.

    Population Inclusion criteria

    • Histologically confirmed neuroendocrine carcinoma of the skin (Merkel cell carcinoma) with inoperable local-regional disease or distant metastatic disease (stages IIIB or IV AJCC 2010), cerebral nervous system metastases will be allowed.
    • First line of treatment or mor
      Sponsor: University Hospital, Grenoble

      Current Primary Outcome: Percentage of patient with positive response according to the RECIST 1.1 criteria [ Time Frame: at 3 months ]

      Positive response will be defined according to the RECIST 1.1 criteria


      Original Primary Outcome: Same as current

      Current Secondary Outcome:

      • Percentage of patient with positive response according to the RECIST 1.1 criteria [ Time Frame: at 6, 9,12,18 and 24 months ]
        Positive response will be defined according to the RECIST 1.1
      • Number of Participants with Adverse Events [ Time Frame: at 3,6, 9,12,18 and 24 months ]
        Description of the safety and tolerability of lanreotide in this study


      Original Secondary Outcome: Same as current

      Information By: University Hospital, Grenoble

      Dates:
      Date Received: January 13, 2015
      Date Started: April 2015
      Date Completion: April 2019
      Last Updated: February 21, 2017
      Last Verified: February 2017