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

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ClinicalTrials.gov Identifier: NCT00326469
Recruitment Status : Completed
First Posted : May 16, 2006
Last Update Posted : December 1, 2010
Sponsor:
Information provided by:
Ipsen

Brief Summary:
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 or disease Intervention/treatment Phase
Neuroendocrine Tumours Drug: lanreotide (Autogel formulation) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2006
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009


Arm Intervention/treatment
Experimental: 1 Drug: lanreotide (Autogel formulation)
120mg administered via deep subcutaneous injection every 28 days for up to 24 months or until disease progression.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Identify tumour growth stabilization predictive factors under treatment with lanreotide Autogel [ Time Frame: Month 3, 6, 9, 12, 18, 21 and 24 ]
  3. Tolerance [ Time Frame: All visits ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
H. Santa Creu i Sant Pau
Barcelona, Spain, 08025
H. Clínic i Provincial
Barcelona, Spain, 08036
Corporación H. Parc Tauli
Barcelona, Spain, 08208
Consorci Sanitari de Terrassa
Barcelona, Spain, 08227
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. 12 de Octubre
Madrid, Spain, 28041
H. Severo Ochoa
Madrid, Spain, 28911
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
Hospital Universitario "Dr. Peset"
Valencia, Spain, 446017
H. La Fe
Valencia, Spain, 46009
H. Hospital General Universitario de Valencia
Valencia, Spain, 46014
H. Miguel Servet
Zaragoza, Spain, 50009
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Eva Pineda, MD Ipsen

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
First Posted: May 16, 2006    Key Record Dates
Last Update Posted: December 1, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Lanreotide
Angiopeptin
Somatostatin
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs