A study of the combination of cetuximab and methotrexate in recurrent or metastatic cancer of the head and neck.

• Conditions: Recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-002886-20-NL
• Lead Sponsor: MC St Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-06
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Histology and disease stage
? Recurrent or metastatic SCCHN.
? No prior systemic treatment for recurrent or metastatic disease.
? Primary site: oral cavity, oropharynx, hypopharynx or larynx.
? Time between prior treatment and inclusion in the study (> 3 months).
General conditions
? Written informed consent.
? WHO performance status 0-2.
? Normal number of neutrophils and trombocytes.
? Normal hepatic function.
? Renal function: calculated creatinin clearance > 60ml/min.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

General conditions
? Serious active infections.
? Pregnancy or lactation.
? Patients (M/F) with reproductive potential not implementing adequate contraceptives measures.
Prior history
? Prior treatment with EGFR inhibitors or methotrexate.
Concomitant treatments
? Concomitant (or within 4 weeks before randomization) administration of any other experimental drug under investigation.
? Concurrent treatment with any other anti-cancer therapy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified