Clinical trial NCT00326469: Efficacy and Safety of Lanreotide Autogel in Tumour Stabilization of Patients With Progressive Neuroendocrine Tumours
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuroendocrine Tumours
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2006-05-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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).
timeFrame: Month 3, 6, 9, 12, 15, 18, 21 and 24
Secondary outcomes:
measure: 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
timeFrame: Month 3, 6, 9, 12, 15, 18, 21 and 24
measure: Identify tumour growth stabilization predictive factors under treatment with lanreotide Autogel
timeFrame: Month 3, 6, 9, 12, 18, 21 and 24
measure: Tolerance
timeFrame: All visits
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: H. Juan Canalejo
city: Alcoy
country: Spain
facility: H. Virgen de los Lirios
city: Alicante
country: Spain
facility: H. General Univ. de Alicante
city: Badalona
country: Spain
facility: H. Germans Trias i Pujol
city: Barcelona
country: Spain
facility: H. Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: H. Clínic i Provincial
city: Barcelona
country: Spain
facility: Corporación H. Parc Tauli
city: Barcelona
country: Spain
facility: Consorci Sanitari de Terrassa
city: Barcelona
country: Spain
facility: H. General de Hospitalet
city: Bilbao
country: Spain
facility: H. de Basurto
city: Elche
country: Spain
facility: H. General de Elche
city: Madrid
country: Spain
facility: H. de la Princesa
city: Madrid
country: Spain
facility: H. Ramón y Cajal
city: Madrid
country: Spain
facility: H. Clínico Univ. San Carlos
city: Madrid
country: Spain
facility: H. 12 de Octubre
city: Madrid
country: Spain
facility: H. Severo Ochoa
city: Palma de Mallorca
country: Spain
facility: Fundación H. Son Llàtzer
city: Pontevedra
country: Spain
facility: Consorcio H. de Pontevedre
city: Sagunto
country: Spain
facility: H. de Sagunto
city: Salamanca
country: Spain
facility: H. Clínico de Salamanca
city: San Sebastián
country: Spain
facility: Int. Oncológico San Sebastián
city: Santander
country: Spain
facility: H. Marques de Valdecilla
city: Tenerife
country: Spain
facility: H. Univ. de Canarias
city: Valencia
country: Spain
facility: Hospital Universitario "Dr. Peset"
city: Valencia
country: Spain
facility: H. La Fe
city: Valencia
country: Spain
facility: H. Hospital General Universitario de Valencia
city: Zaragoza
country: Spain
facility: H. Miguel Servet
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: Martin-Richard M, Massuti B, Pineda E, Alonso V, Marmol M, Castellano D, Fonseca E, Galan A, Llanos M, Sala MA, Pericay C, Rivera F, Sastre J, Segura A, Quindos M, Maisonobe P; TTD (Tumores del Tracto Digestivo) Study Group. Antiproliferative effects of lanreotide autogel in patients with progressive, well-differentiated neuroendocrine tumours: a Spanish, multicentre, open-label, single arm phase II study. BMC Cancer. 2013 Sep 20;13:427. doi: 10.1186/1471-2407-13-427.