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Image Guided Treatment Optimization With Cetuximab for Patients With Metastatic Colorectal Cancer

NCT02117466 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2021-04-14

No results posted yet for this study

Summary

In this study the investigators will evaluate the uptake of 89Zirconium labeled cetuximab in extra-hepatic colorectal metastases. The investigators hypothesize that uptake of 89Zr-cetuximab is required for response to cetuximab. If no uptake is present the investigators will escalate the dose cetuximab and repeat the 89Zr-cetuximab PET.

The investigators will evaluate the clinical benefit rate of cetuximab in the patients with and without uptake. The ultimate goal is to create a selection tool that can predict response of cetuximab.

Conditions

Interventions

DRUG

Dose escalation cetuximab

dose escalation of cetuximab (described in the second arm)

DRUG

Standard dose cetuximab

500mg/m2 bsa cetuximab (described in the first arm)

Sponsors & Collaborators

  • University Medical Center Groningen

    collaborator OTHER

  • Radboud University Medical Center

    collaborator OTHER

  • Amsterdam UMC, location VUmc

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2021-01-31
Completion
2021-01-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02117466 on ClinicalTrials.gov