89Zr-bevacizumab PET Imaging in Patients With Neuroendocrine Tumors

NCT01338090 | Completed DMC

• 2 other identifiers: 200911042009-017195-24
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuroendocrine Tumors

Keywords

VEGF imaging; neuroendocrine tumors; biomarker; mTOR inhibition

Outcome Measures

Primary Outcomes (1)

• change in 89Zr-bevacizumab uptake

  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. In addition, effect sizes and confidence intervals will be determined.

  12 weeks

Secondary Outcomes (1)

• Progressive disease

  12 weeks

Study Arms (1)

89Zr-bevacizumab

Drug: 89Zr-bevacizumab; Drug: Everolimus

Interventions

89Zr-bevacizumab DRUG

Intravenous injection 120 MBq

89Zr-bevacizumab

Everolimus DRUG

Oral use, 10 mg per day

Also known as: RAD001

89Zr-bevacizumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with metastatic neuroendocrine tumors.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

89Zr-bevacizumab; Everolimus

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Elisabeth GE de Vries, MD, PHD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 12, 2011
• First Posted: April 19, 2011
• Study Start: April 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 3, 2012

Record last verified: 2011-08

Locations

NL (1)