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Non Invasive Imaging of Cetuximab-Zirconium-89 Uptake With PET: a Phase I Trial in Stage IV Cancer

Phase 1
18 Years
Open (Enrolling)
Stage IV Cancer

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Trial Information

Non Invasive Imaging of Cetuximab-Zirconium-89 Uptake With PET: a Phase I Trial in Stage IV Cancer

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 Zr89 is 4 x 3.2 days = 12.8 days), no additional toxic effect is
expected. Blood sampling will be done weekly (haematology, liver and kidney function).

When in 0/3 patients a toxicity of grade 3 or more has occurred step 2 is considered safe.
If in 1/3 patients a grade 3 has occurred, 3 more patients will be included in this step. If
another grade 3 toxicity occurs in 1/3 patients, the study will be stopped. When at maximum
1/6 patients experience a grade 3 toxicity, this step will be considered safe. When step 2
is considered safe, the study is ended.

After the injection, visualization of all tumour sites will be analyzed by performing a
PET-CT scan on day 4, 5 and 6 post injection. An additional scan on day 3 or 7 is optional.*
At day 5 post injection a perfusion PET-CT will be performed.

Inclusion Criteria

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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Toxicity (CTCAE 3.0)

Outcome Time Frame:

2 weeks

Safety Issue:


Principal Investigator

Dirk De Ruysscher, Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Maastro Radiation Oncology


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

Cetuximab-Zr.89 fase I



Start Date:

June 2009

Completion Date:

September 2013

Related Keywords:

  • Stage IV Cancer
  • Stage IV cancer