Efficacy and Safety of Lanreotide Autogel in Tumour Stabilization of Patients With Progressive Neuroendocrine Tumours

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00326469
First received: May 15, 2006
Last updated: November 30, 2010
Last verified: November 2010
  Purpose

To evaluate, in patients with progressive neuroendocrine tumours who are not eligible to be treated with either surgery or chemotherapy at the moment of study inclusion, the efficacy of lanreotide Autogel in tumour growth stabilization.


Condition Intervention Phase
Neuroendocrine Tumours
Drug: lanreotide (Autogel formulation)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II, Open, Single Group, Multicentre Study to Evaluate the Efficacy and Safety of Lanreotide Autogel Administered Every 4 Weeks by Deep Subcutaneous Injection in the Tumour's Growth Stabilization of Patients With Progressive Neuroendocrine Tumours Who Are Not Eligible to be Treated With Either Surgery or Chemotherapy

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Time to disease progression (appearance of 1+ new lesions or increase >or= to 20% of sum of the longest diameters of target lesions compared to the lower sum of maximum diameters recorded since the start of the study). [ Time Frame: Month 3, 6, 9, 12, 15, 18, 21 and 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate efficacy related to tumour's partial or total response, biological disease markers response, symptomatic control, effect of treatment on patient's quality of life [ Time Frame: Month 3, 6, 9, 12, 15, 18, 21 and 24 ] [ Designated as safety issue: No ]
  • Identify tumour growth stabilization predictive factors under treatment with lanreotide Autogel [ Time Frame: Month 3, 6, 9, 12, 18, 21 and 24 ] [ Designated as safety issue: No ]
  • Tolerance [ Time Frame: All visits ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: May 2006
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: lanreotide (Autogel formulation)
120mg administered via deep subcutaneous injection every 28 days for up to 24 months or until disease progression.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with histopathologic diagnosis of well-differentiated neuroendocrine tumour or carcinoma according to WHO classification
  • patients who, according to RECIST criteria (Response Evaluation Criteria in Solid Tumours) present measurable disease
  • patients with progressive disease in the previous 6 months before their inclusion in the study
  • patients with positive IN111 octreotide scintigraphy

Exclusion Criteria:

  • patients with surgically removable localised disease
  • patients with progressive disease in the first six months of being diagnosed
  • patients with intestinal obstruction due to a carcinoid tumour
  • patients who have received treatment with somatostatin analogues during the 6 months before being included in the study
  • patients who have received treatment with radiotherapy, chemotherapy or interferon 4 weeks before being included in the study, or planned to receive these during the study
  • patients who have received treatment with liver artery embolisation or radiopharmaceuticals (endoradiotherapy) 12 weeks before being included in the study, or planned during the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326469

Locations
Spain
H. Juan Canalejo
A Coruña, Spain, 15006
H. Virgen de los Lirios
Alcoy, Spain, 03804
H. General Univ. de Alicante
Alicante, Spain, 03010
H. Germans Trias i Pujol
Badalona, Spain, 08916
Corporación H. Parc Tauli
Barcelona, Spain, 08208
Consorci Sanitari de Terrassa
Barcelona, Spain, 08227
H. Clínic i Provincial
Barcelona, Spain, 08036
H. Santa Creu i Sant Pau
Barcelona, Spain, 08025
H. de Basurto
Bilbao, Spain, 48013
H. General de Elche
Elche, Spain, 03203
H. General de Hospitalet
Llobregat, Spain, 08906
H. de la Princesa
Madrid, Spain, 28006
H. Ramón y Cajal
Madrid, Spain, 28034
H. Clínico Univ. San Carlos
Madrid, Spain, 28040
H. Severo Ochoa
Madrid, Spain, 28911
H. 12 de Octubre
Madrid, Spain, 28041
Fundación H. Son Llàtzer
Palma de Mallorca, Spain, 07198
Consorcio H. de Pontevedre
Pontevedra, Spain, 36001
H. de Sagunto
Puerto de Sagunto, Spain, 46520
H. Clínico de Salamanca
Salamanca, Spain, 37007
Int. Oncológico San Sebastián
San Sebastián, Spain, 20012
H. Marques de Valdecilla
Santander, Spain, 39008
H. Univ. de Canarias
Tenerife, Spain, 38320
H. La Fe
Valencia, Spain, 46009
H. Hospital General Universitario de Valencia
Valencia, Spain, 46014
Hospital Universitario "Dr. Peset"
Valencia, Spain, 446017
H. Miguel Servet
Zaragoza, Spain, 50009
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Eva Pineda, MD Ipsen
  More Information

No publications provided by Ipsen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eva Pineda, Ipsen
ClinicalTrials.gov Identifier: NCT00326469     History of Changes
Other Study ID Numbers: A-92-52030-166
Study First Received: May 15, 2006
Last Updated: November 30, 2010
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Neoplasms
Neuroendocrine Tumors
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Angiopeptin
Lanreotide
Antineoplastic Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014