An open, non-randomized phase-2 study of efficacy and safety of treatment with 177Lutetium-DOTA0-Tyr3-octreotate in patients with neuroendocrine tumors

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2009-012260-14-SE
• Date of registration: 28/10/2009
• Prospective Registration: Yes
• Primary sponsor: Department of Endocrine Oncology
• Public title: An open, non-randomized phase-2 study of efficacy and safety of treatment with 177Lutetium-DOTA0-Tyr3-octreotate in patients with neuroendocrine tumors
• Scientific title: An open, non-randomized phase-2 study of efficacy and safety of treatment with 177Lutetium-DOTA0-Tyr3-octreotate in patients with neuroendocrine tumors
• Date of first enrolment: 27/08/2010
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-012260-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: yes Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
• Patients either with carcinoids originating from lung, thymus, stomach, duodenum, small bowel, large bowel, rectum, or
• Patients with endocrine pancreatic tumours, or
• Patients with malignant pheochromocytoma/paraganglioma
• Uptake at least grade 3 according to Krenning sckale (0–4) at OctreoScan, (i.e. somatostatin receptor expression higher than normal liver), not older than 6 months
• Life exspektancy more than 3 months
• WBC >3,0x109/L
• Neutrophils >1,5x109/L
• Platelet count >100x109/L
• Bilirubin <40 µmol/L
• Albumin >25 g/L
• ASAT/ALAT =5 times upper reference limit
• Creatinine <110 µmol/L
• GFR =50 ml/min/1,73
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• Tumors accessible to surgery or radiofrequency ablation
• Decreased renal function: Creatinine >110 µmol/L and/or GFR <50 ml/min/1,73
• Platelet count <100x109/L
• WBC <3,0x109/L
• Neutrophils <1,5x109/L
• Moderately/severely impaired liver function
• Very large tumour load in the liver with high uptake on OctreoScan
• Pregnancy
• Inability to manage the personal hygiene
• Inablity to be isolated for 24 hours
• Proliferation >20–30% (Ki67-positive tumour cells)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients with malignant neuroendocrine tumours, not amenable to surgical treatment or radiofrequency ablation. Renal, bone marrow and liver function must be sufficient.

Intervention(s)

Trade Name: 177-LuDOTA-Tyr3-Octreotate
Product Name: 177-LuDOTA-Tyr3-Octreotate
Pharmaceutical Form: Solution for infusion

Primary Outcome(s)

Main Objective: Clarify the effect of the treatment with 177-Lu-DOTA-octreotate, regarding a) tumour size b) biochemical response, c) prognostic factors such as proliferation markers and LD/ALP and type of tumour, d) quality of life, e) survival and f) progression free survival.

Primary end point(s): Radiological response rate according to RECIST criteria

Secondary Objective: Optimize the treatment based on a dosimetry protocol developed in Uppsala. Is it possible to safely administer more than the four treatments from the Rotterdam protocol based on this dosmetry model, and can the therapeutic effect be further improved over time?

Secondary ID(s)

20050418