89Zr-bevacizumab PET imaging as predictive biomarker for everolimus efficacy in patients with neuroendocrine tumors

Completed

Conditions: hormone producing cancer
neuroendocrine tumors
10014713

Registration Number: NL-OMON32849

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 14

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: <= 1.5 x ULN, ALT and AST <= 2.5x ULN. Patients with known liver metastases: AST and ALT <= 5x ULN.
• Adequate renal function: serum creatinine <= 1.5 x ULN.
• Fasting serum cholesterol <=300 mg/dL OR 7.75 mmol/L AND fasting triglycerides <= 2.5 x ULN. NOTE: In cases where one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication,

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).

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the change in 89Zr-bevacizumab uptake in tumor lesions<br /><br>between the baseline PET scan and the scans performed after 2 and 12 weeks of<br /><br>everolimus treatment in patients with neuroendocrine tumors.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoint is progressive disease according to Response Evaluation<br /><br>Criteria in Solid Tumors (RECIST) criteria on CT after 12 weeks of treatment.<br /><br>Progression is defined as the appearance of new disease or an increase of 20%<br /><br>in the sum of the longest diameters of the target lesions.</p><br>