Non-invasive Imaging of Cetuximab-Zr. 89 Uptake Wit PET: a Phase I Trial in Stage IV Cancer Patients

NCT00691548 | Completed Phase 1 DMC

• 2 other identifiers: Cetuximab-Zr.89 fase I08-3-039 (MEC)
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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 antibodies labelled with Zirconium-89 have already been used with success in patients. The combination of cetuximab labelled with Zirconium-89 is a promising new probe to determine cetuximab uptake, which has been tested in various pre-clinical animal models in Maastricht with excellent results. We propose a two step study design (see figure 1). As our ultimate goal for the future is to determine the uptake of 89Zr-cetuximab in the tumour before and during therapy, we need to investigate the toxicity of two consecutive low doses of 89Zr-cetuximab in the first place. However, as in future studies and in some patients, it is also possible that a single, larger dose of 89Zr-cetuximab is needed to obtain the best image quality, we will also investigate the toxicity of a single larger dose. Step 1: Determination of the toxicity of two low doses of 89Zr-cetuximab In three patients a standard loading dose of 400 mg/m2 of cetuximab will be administered, partly labelled with 89Zr (60 MBq, 2.5mg) on day 0. On day 14, a second injection with dose of 250 mg/m2 of cetuximab, partly labelled with 89Zr (60 MBq, 2.5mg), will be given. Step 2: Determination of the toxicity of one larger dose of 89Zr-cetuximab A standard loading dose of 400 mg/m2 of cetuximab will be administered in 3 patients, a part labelled with 89Zr (120MBq, 5mg).

Conditions

Stage IV Cancer

Keywords

Stage IV cancer

Outcome Measures

Primary Outcomes (1)

• Toxicity (CTCAE 3.0)

  2 weeks

Secondary Outcomes (1)

• Image Quality (Tumour-to-Background Ratio)

  4 weeks

Study Arms (1)

1

EXPERIMENTAL

Drug: Cetuximab-Zr. 89

Interventions

Cetuximab-Zr. 89 DRUG

Step 1: Determination of the toxicity of two low doses of 89Zr-cetuximab In three patients a standard loading dose of 400 mg/m2 of cetuximab will be administered, partly labelled with 89Zr (60 MBq, 2.5mg) on day 0. On day 14, a second injection with dose of 250 mg/m2 of cetuximab, partly labelled with 89Zr (60 MBq, 2.5mg), will be given. Step 2: Determination of the toxicity of one larger dose of 89Zr-cetuximab A standard loading dose of 400 mg/m2 of cetuximab will be administered in 3 patients, a part labelled with 89Zr (120MBq, 5mg).

1

Eligibility Criteria

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

You may qualify if:

• 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

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead
• Amsterdam UMC, location VUmc: collaborator

Study Sites (1)

Maastro Clinic

Maastricht, 6229 ET, Netherlands

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Dirk De Ruysscher, Dr.

  Maastro Radiation Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2008
• First Posted: June 5, 2008
• Study Start: June 1, 2009
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 10, 2015

Record last verified: 2015-04

Locations

NL (1)