drugset / Trial / NCT02054442
A Study of the Combination of Cetuximab and Methotrexate in Recurrent or Metastatic Cancer of the Head and Neck
Phase 1/2
Unknown
52 enrolled
Radboud University Medical Center
Academisch Ziekenhuis Maastricht · collabElisabeth-TweeSteden Ziekenhuis · collabErasmus Medical Center · collabFrisius Medisch Centrum · collabLeiden University Medical Center · collabMedical Center Haaglanden · collabMedisch Spectrum Twente · collabMerck Serono International SA · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2016-08
- Primary completion
- 2021-12
- Completion
- 2022-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | 250 mg/m2 | Intravenous |
| Subject | Methotrexate | Small molecule | 40 mg/m2 | Intravenous |