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A Study of the Combination of Cetuximab and Methotrexate in Recurrent or Metastatic Cancer of the Head and Neck

NCT02054442 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2021-03-12

No results posted yet for this study

Summary

The investigators will perform a randomized phase II study to investigate if the addition of cetuximab to MTX is beneficial for the patient. Because no data on this combination are available the investigators will start with a phase Ib study to investigate the feasibility of the schedule.

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Interventions

DRUG

Cetuximab

We will perform a randomized phase II study to investigate in first line if the addition of cetuximab to MTX is beneficial, i.e. improvement in the PFS, for the patient.

DRUG

Methotrexate

Sponsors & Collaborators

  • Merck Serono International SA

    collaborator INDUSTRY

  • Leiden University Medical Center

    collaborator OTHER

  • Academisch Ziekenhuis Maastricht

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • Medisch Spectrum Twente

    collaborator OTHER

  • Medical Center Haaglanden

    collaborator OTHER

  • Elisabeth-TweeSteden Ziekenhuis

    collaborator OTHER

  • Frisius Medisch Centrum

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Carla M van Herpen, MD, PhD · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2021-12-31
Completion
2022-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT02054442 on ClinicalTrials.gov