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Trial · Interventional

CompletedPhase 2Registry data

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

Short name PHRC-Merkel

NCTNCT02351128 (opens ClinicalTrials.gov in a new tab)Other id38RC14.040Other id2014-001273-13Other id2014
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
35 participants (actual)
Sponsor
University Hospital, Grenoble · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

France

Start
Apr 2015
Primary completion
15 May 2017
Completion
15 May 2017
First posted
30 Jan 2015 (estimated)
Last update posted
18 Oct 2017
Conditions
Carcinoma, Merkel Cell

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2015201620172018
  1. Ph 2

    PHRC-Merkel

    NCT02351128

    Apr 2015 to 15 May 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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 data, other analogues or hybrid molecules; * consider, if positive results are obtained from this study, somatostatin analogues as adjuvant treatment after surgery of primary MCC.

Interventions

  • LanreotideDrug

Arms1

  • Experimental

    Only one arm

    All patients receive Lanreotide.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of patient with positive response according to the RECIST 1.1 criteria

    Time frame · at 3 months

    Registry description

    Positive response will be defined according to the RECIST 1.1 criteria

Secondary outcomes(2)

  1. Percentage of patient with positive response according to the RECIST 1.1 criteria

    Time frame · at 6, 9,12,18 and 24 months

    Registry description

    Positive response will be defined according to the RECIST 1.1

  2. Number of Participants with Adverse Events

    Time frame · at 3,6, 9,12,18 and 24 months

    Registry description

    Description of the safety and tolerability of lanreotide in this study

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2026

7 results

Lanreotide, a Somatostatin Analogue, in Advanced Merkel Cell Carcinoma: A Prospective Single-Arm Phase II Study.

Charles et al. 2026Cancer medicine

PMID 42791653PMC13615304DOI 10.1002/cam4.72295PUB-42791653

Free to read · publisher termsCC BY-NC7 results
Read at sourceSee results (7)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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 more * Measurable disease: at least 20 mm by conventional techniques or 10 mm by spiral CT scan * WHO performance status ECOG 0-3 * premenopausal patients must use effective contraception * No other prior malignancy within 5 years except adequately treated basal cell or squamous cell carcinoma or in situ cancer of the cervix * No other concurrent chemotherapy, immunotherapy or hormone therapy. * At least 4 weeks since adjuvant chemotherapy, 14 days since radiotherapy and 2 weeks since surgery * Biological functions: absolute neutrophil count at least 1000/mm3, platelet count at least 100000/mm3, haemoglobin at least 9g/dl (transfusion allowed), bilirubin no greater than 3 times upper limit of normal (ULN), SGOT and SGPT no greater than 2.5 times ULN, no untreated chronic liver disease, creatinine no greater than 1.5 times ULN, no untreated chronic renal disease, no untreated diabetes or infection * Written informed consent Exclusion Criteria: * previous hypersensibility to lanreotide treatment * complicated and untreated cholelithiasis * pregnancy or breast-feeding * patient treated with cyclosporine

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