Treatment optimization of cetuximab in patients with metastatic colorectal cancer based on tumour uptake of 89Zr-labeled cetuximab assessed by PET

Completed

Conditions: metastazised colorectal cancer
advanced intestinal cancer
10017991

Registration Number: NL-OMON36409

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 38

Inclusion Criteria

Advanced colorectal adenocarcinoma
Subjects must have been treated according to standard care with a fluoropyrimidine (e.g. fluorouracil or capecitabine), irinotecan, and oxaliplatin or had contra-indications to treatment with these drugs.
Tumour material must be tested wild type for the K-Ras gene.
Subjects have at least one measurable lesion outside the liver.
ECOG Performance Status of 0, 1 or 2

Exclusion Criteria

Previous exposure to an anti-EGFR therapy
Significant skin condition interfering with treatment
Insulin dependency
Concurrent anticancer chemotherapy, immunotherapy or investigational drug therapy during the study or within 4 weeks of the start of study drug.
Radiotherapy to the target lesions during study or within 4 weeks of the start of study drug. Palliative radiotherapy will be allowed.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Part One:<br /><br>The detection of 89Zr-cetuximab uptake in non-hepatic tumour lesions<br /><br>(present/absent; present being defined as levels measured in ROIs > standard<br /><br>deviation of background +1).<br /><br><br /><br><br /><br>Part two:<br /><br>The % uptake (of total injected) 89Zr-cetuximab in non-hepatic tumour lesions<br /><br>as measured in ROIs corrected for background levels.<br /><br>Treatment response as measured by RECIST 1.1 criteria</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) The % uptake (of total injected) 89Zr-cetuximab in liver lesions as measured<br /><br>in ROI*s corrected for background levels.<br /><br>2) [18F-]FDG PET measurements (SUVmax) before and after 4 weeks of treatment<br /><br>with cetuximab.<br /><br>3) Grade of skin toxicity as measured by predefined criteria.<br /><br><br /><br><br /><br>Other study parameters<br /><br>4) Serum magnesium levels before and during treatment.<br /><br>5) EGFR saturation with cetuximab in skin samples.<br /><br>6) Kinase activity in skin samples before and during treatment with cetuximab.<br /><br>7) Pharmacokinetics of 89Zr-cetuximab.</p><br>