Recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN)
Conditions
Interventions
Trade Name: Erbitux
Product Name: Erbitux
Product Code: EMD271786
Pharmaceutical Form: Solution for infusion
Trade Name: EMTHEXATE
Pharmaceutical Form: Solution for injection
Sponsors
UMC St Radboud
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: • Phase Ib: to assess the feasibility and safety of the addition of cetuximab to methotrexate for recurrent or metastatic SCCHN • Phase II: to assess the efficacy of the addition of cetuximab to methotrexate for recurrent or metastatic SCCHN ;Secondary Objective: Secondary objectives: In both the phase Ib and phase II • To assess overall survival (OS) • To assess response rate (RR) • To assess toxicity • To assess quality of life (QoL) • To assess HPV positivity in relation to PFS/OS/response;Primary end point(s): Primary endpoints: • Phase Ib: Toxicity scored with CTC v 4.0*; dose limiting toxicity (DLT) during the first 4 weeks after start of the combination • Phase II: PFS *Toxicity scored according CTC v 4.0 will be done during the complete study period both in the phase Ib and phase II study ;Timepoint(s) of evaluation of this end point: Phase Ib: Toxicity scored with CTC v 4.0*; dose limiting toxicity (DLT) during the first 4 weeks after start of the combination After end of the study treatment, the patient will be followed for PFS (in case PD was not the reason to stop treatment) and OS. In case the reason to stop was not PD, tumor measurements will be performed every 8 weeks and PS will be recorded. In case the patient will not attend the clinic anymore, we will contact the general practitioner for survival data. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: • OS • RR according to RECIST 1.1 • Quality of life (QoL);Timepoint(s) of evaluation of this end point: After end of the study treatment, the patient will be followed for PFS (in case PD was not the reason to stop treatment) and OS. In case the reason to stop was not PD, tumor measurements will be performed every 8 weeks and PS will be recorded. In case the patient will not attend the clinic anymore, we will contact the general practitioner for survival data. Efficacy: Every 8 weeks CT or MRI scanning will be done for tumor evaluation according to RECIST 1.1 (21). The timing of QoL and local symptom assessments will be at baseline after 8 weeks, 24 weeks, after 1 year and at PD. | — |
Countries
Netherlands
Contacts
Public ContactC.M.L. van Herpen, MD, PhD
UMC St Radboud
Outcome results
None listed