DRUG
lanreotide (Autogel formulation)
120mg administered via deep subcutaneous injection every 28 days for up to 24 months or until disease progression.
Status
Completed
Phase
Phase 2
Enrollment
30
Locations
27
Results
Not posted
Publications
1
Study 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.
Interventions
DRUG
120mg administered via deep subcutaneous injection every 28 days for up to 24 months or until disease progression.
Timeline
First posted
May 16, 2006
Study start
May 2006
Primary completion
Nov 2009
Study completion
Nov 2009
Results posted
Not reported
Registry updated
Nov 5, 2020
Outcomes
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
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
Identify tumour growth stabilization predictive factors under treatment with lanreotide Autogel
Time frame · Month 3, 6, 9, 12, 18, 21 and 24
Tolerance
Time frame · All visits
Eligibility
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.
Study locations
Spain. Showing up to 24 locations stored in the fast local snapshot.
H. Juan Canalejo
A Coruña, Spain
H. Virgen de los Lirios
Alcoy, Spain
H. General Univ. de Alicante
Alicante, Spain
H. Germans Trias i Pujol
Badalona, Spain
H. Santa Creu i Sant Pau
Barcelona, Spain
H. Clínic i Provincial
Barcelona, Spain
Corporación H. Parc Tauli
Barcelona, Spain
Consorci Sanitari de Terrassa
Barcelona, Spain
H. General de Hospitalet
Barcelona, Spain
H. de Basurto
Bilbao, Spain
H. General de Elche
Elche, Spain
H. de la Princesa
Madrid, Spain
H. Ramón y Cajal
Madrid, Spain
H. Clínico Univ. San Carlos
Madrid, Spain
H. 12 de Octubre
Madrid, Spain
H. Severo Ochoa
Madrid, Spain
Fundación H. Son Llàtzer
Palma de Mallorca, Spain
Consorcio H. de Pontevedre
Pontevedra, Spain
H. de Sagunto
Sagunto, Spain
H. Clínico de Salamanca
Salamanca, Spain
Int. Oncológico San Sebastián
San Sebastián, Spain
H. Univ. de Canarias
Santa Cruz de Tenerife, Spain
H. Marques de Valdecilla
Santander, Spain
Hospital Universitario "Dr. Peset"
Valencia, Spain
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