A phase Ib-II study of the combination of cetuximab and methotrexate in recurrent or metastatic squamous cell carcinoma of the head and neck. A study of the Dutch Head and Neck Society. DHNS 2013-01 / MOHN01

Phase 2

Completed

• Conditions: cancer of the head and neck; Squamous cell carcinoma of the head and neck; 10027655

• Registration Number: NL-OMON40553
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

• Cytologically/histologically-proven SCCHN
• Recurrent or metastatic SCCHN
• At least one measurable as determined by RECIST v1.1 is required. Lesions in previously irradiated areas should not be considered measurable unless there is clear evidence of progression in such lesions since the radiotherapy.
• 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). Palliative RT in case of painful bone metastases is allowed in phase II and after 4 weeks in phase Ib
• Ineligible (due to medical co-morbidities) or intolerant to platinum-based therapy per medical history or refusing cisplatin-based chemotherapy by the patient
• WHO performance status 0-2.
• Age * 18 years
• Adequate organ function and laboratory parameters as defined by:
o Absolute neutrophil count (ANC) >= 1.5 x 109 /L
o Hemoglobin (Hb) >= 9 g/dl=5.6 mmol/l (which may be achieved by transfusion)
o Platelets (PLT) >= 100 x 109/L
o AST and ALT <= 2.5 x ULN (upper limit of normal)
o Serum bilirubin <= 1.5 x ULN
o Calculated creatinine clearance or MDRD > 60ml/min
• Recovered from all adverse events (AEs) of previous anti-cancer therapies. AEs related to prior radiotherapy are allowed.
• Written informed consent

Exclusion Criteria

• Serious active infections
• Patients (M/F) with reproductive potential not implementing adequate contraceptives measures
• Prior treatment with EGFR inhibitors or MTX
• Concomitant (or within 4 weeks before randomization) administration of any other experimental drug under investigation
• Concurrent treatment with any other anti-cancer therapy.
• Central nervous system involvement
• Lung fibrosis
• Pleural effusion or ascites or other third space effusions
• History of another malignancy within 2 years prior to starting study treatment, except cured basal cell carcinoma of the skin, excised carcinoma in situ of the cervix, or other head and neck cancer.
• Pregnancy or lactation
• Any other condition that would, in the Investigator*s judgment, preclude patient*s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g. infection/inflammation, intestinal obstruction, social/psychological complications.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints:<br /><br>• Phase Ib: Toxicity scored with CTC v 4.0*; dose limiting toxicity (DLT)<br /><br>during the first 4 weeks after start of the combination<br /><br>• Phase II: PFS<br /><br><br /><br><br /><br>*Toxicity scored according CTC v 4.0 will be done during the complete study<br /><br>period both in the phase Ib and phase II study</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>• OS<br /><br>• RR according to RECIST 1.1<br /><br>• Quality of life (QoL)</p><br>