89Zr-bevacizumab PET Imaging in Patients With Neuroendocrine Tumors

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a pilot study for evaluation of 89Zr-bevacizumab PET imaging as predictive biomarker during treatment with everolimus in patients with neuroendocrine tumors.

Patients with progressive disease during the last year will receive treatment with everolimus 10 mg/day orally and 89Zr-bevacizumab PET imaging will be performed before start of treatment and after 2 and 12 weeks of treatment in the first three patients. If the scan after 2 weeks of treatment is already informative further patients will not undergo a scan at 12 weeks. A scan is considered already informative if both scans show at least 30% decrease in uptake in case of response, or at least 30% increase in uptake in case of disease progression.

Four days before the scan patients will be injected intravenously 37 MBq, protein dose 5 mg 89Zr-bevacizumab. At day 1, day 15 and day 99, PET images will be made for visualization and quantification of VEGF in the tumor lesions and blood will be drawn for determination of angiogenesis and mTOR pathway related biomarkers.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen
• Collaborator: Novartis Pharmaceuticals
• Treatments: 89Zr-bevacizumab; Bevacizumab; Everolimus; Sirolimus

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: ≤ 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)

• any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule of the study

• Patients with uncontrolled diabetes mellitus as defined by fast blood sugar > 1.5 x ULN.

• Prior therapy with RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus).

• Concomitant medications known to inhibit, induce or be a substrate to isoenzyme CYP3A are excluded unless the drugs are medically necessary and no substitutes are available. If there are no acceptable substitutes, special precautions should be taken in these patients