eoadjuvant cetuximab monotherapy followed by surgery in squamous cell carcinoma of head and neck: phase I/II study - Chiron 2008-01

Phase 1

• Conditions: patients with squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx newly diagnosed and eligible for surgery.; MedDRA version: 9.1Level: LLTClassification code 10041857Term: Squamous cell carcinoma of the oral cavity; MedDRA version: 9.1Level: LLTClassification code 10031112Term: Oropharyngeal squamous cell carcinoma; MedDRA version: 9.1Level: LLTClassification code 10021042Term: Hypopharyngeal cancer; MedDRA version: 9.1Level: LLTClassification code 10023856Term: Laryngeal squamous cell carcinoma

• Registration Number: EUCTR2008-001354-41-BE
• Lead Sponsor: Cliniques Universitaires St Luc, Centre du Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-27
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

•Age 18 years and over
•Histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
•Patients selected for a primary surgical treatment
•No distant metastases
•No contraindications to cetuximab
• No active second malignancy during the last five years except non melanomatous skin cancer or carcinoma in situ of the cervix
•No prior or concurrent evidence of uncontrolled severe pathology precluding administration of surgery (i.e. unstable cardiopathy,…)
•Life expectancy of 3 months
•Not pregnant or nursing: fertile patients must use effective contraception
•Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
•Signed informed consent.
•Performance status ECOG 0-1

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Nasopharynx cancer
•Past or current malignancy other than HNSCC, except for:
•Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
•Neutrophils count = 1,500/mm3, platelet count = 75,000/mm3, WBC< 3.0/109 L, bilirubin or creatinine > 2 times ULN, ALAT or ALAP > 5 times ULN.
•Use of any investigational agent(s) within 4 weeks prior to entry
•Previous exposure to EGFR targeting therapy
•Known grade 3 or 4 allergic reaction to any of the components of the treatment

Study & Design

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