Status:
COMPLETED
Non-invasive Imaging of Cetuximab-Zr. 89 Uptake Wit PET: a Phase I Trial in Stage IV Cancer Patients
Lead Sponsor:
Maastricht Radiation Oncology
Collaborating Sponsors:
Amsterdam UMC, location VUmc
Conditions:
Stage IV Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Non invasive imaging of cetuximab uptake with PET could help to select the patients who could be treated by cetuximab, a registered but expensive monoclonal antibody against EGFR. Other monoclonal ant...
Detailed Description
Toxicity will be scored twice a week from the day of first injection (day 0) up to day 14, according to the CTCAE3.0 scoring system. As after 14 days, the activity of Zr89 is low (four half-lives of Z...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Stage IV cancer (primary or recurrent)
- Normal white blood cell count and formula
- Normal platelet count
- No anemia requiring blood transfusion or erythropoietin
- Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution).
- Calculated Creatinin clearance at least 60 ml/min
- No previous administration of cetuximab
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00691548
Start Date
June 1 2009
End Date
March 1 2015
Last Update
April 10 2015
Active Locations (1)
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1
Maastro Clinic
Maastricht, Netherlands, 6229 ET