hormone producing cancer neuroendocrine tumors
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • adult patients with metastatic neuroendocrine tumors • radiological documentation of progressive disease over the past year • measurable disease according to RECIST criteria • Adequate bone marrow function as shown by: ANC >= 1.5 x 109/L, Platelets >= 100 x 109/L, Hb > 9 g/dL. • Adequate liver function: serum bilirubin:
Exclusion criteria
Exclusion criteria: • uncontrolled medical conditions (eg, unstable angina, symptomatic heart failure, serious intercurrent infections, uncontrolled diabetes) • any psychological, familial, sociological condition potentially hampering compliance with the study protocol and follow-up schedule of the study • Prior therapy with RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the change in 89Zr-bevacizumab uptake in tumor lesions between the baseline PET scan and the scans performed after 2 and 12 weeks of everolimus treatment in patients with neuroendocrine tumors. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint is progressive disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria on CT after 12 weeks of treatment. Progression is defined as the appearance of new disease or an increase of 20% in the sum of the longest diameters of the target lesions. | — |
Countries
Netherlands
Outcome results
None listed