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

NCT02351128 | Completed Phase 2

• 2 other identifiers: 38RC14.0402014-001273-13
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Carcinoma, Merkel Cell

Keywords

lanreotide

Outcome Measures

Primary Outcomes (1)

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

  Positive response will be defined according to the RECIST 1.1 criteria

  at 3 months

Secondary Outcomes (2)

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

  at 6, 9,12,18 and 24 months

• Number of Participants with Adverse Events

  at 3,6, 9,12,18 and 24 months

Study Arms (1)

Only one arm

EXPERIMENTAL

All patients receive Lanreotide.

Drug: Lanreotide

Interventions

Lanreotide DRUG

Also known as: Somatuline

Only one arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• previous hypersensibility to lanreotide treatment
• complicated and untreated cholelithiasis
• pregnancy or breast-feeding
• patient treated with cyclosporine

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Grenoble University Hospital

Grenoble, 38 000, France

Location

MeSH Terms

Conditions

Carcinoma, Merkel Cell

Interventions

lanreotide

Condition Hierarchy (Ancestors)

Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• BEYLOT-BARY Marie

  Bordeaux University Hospital, Haut-lévêque

  PRINCIPAL INVESTIGATOR

• DUTRIAUX Carole

  Bordeaux University Hospital, St André

  PRINCIPAL INVESTIGATOR

• DALAC Sophie

  Centre Hospitalier Universitaire Dijon

  PRINCIPAL INVESTIGATOR

• DUPUY Alain

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

• LEBBE Céleste

  AP-HP- Saint Louis

  PRINCIPAL INVESTIGATOR

• AVRIL Marie-Françoise

  AP-HP - Cochin

  PRINCIPAL INVESTIGATOR

• DALLE Stéphane

  HCL- Lyon Sud, Pierre Bénite

  PRINCIPAL INVESTIGATOR

• GUILLOT Bernard

  Montpellier University Hospital

  PRINCIPAL INVESTIGATOR

• VERNEUIL Laurence

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

• DRENO Brigitte

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

• HAINAUT-Wierzbicka Ewa

  Poitiers University Hospital

  PRINCIPAL INVESTIGATOR

• GROB Jean-Jacques

  AP-HM

  PRINCIPAL INVESTIGATOR

• DEQUATREBARBES Julie

  Annecy Interregional Hospital

  PRINCIPAL INVESTIGATOR

• ZEHOU Ouidad

  AP-HP-Henri MONDOR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 30, 2015
• Study Start: April 1, 2015
• Primary Completion: May 15, 2017
• Study Completion: May 15, 2017
• Last Updated: October 18, 2017

Record last verified: 2017-10

Locations

FR (1)