Neoadjuvant Cetuximab in HNSCC Combined With Curative Surgery

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary diagnose HNSCC carcinoma patients eligible for curative surgery will be proposed the addition of 2 or 3 neoadjuvant cetuximab infusions. The main objective is to reduce to a minimal delay the time elapsing between last infusion and surgery.

Iterative biomarkers will be taken at 6 time points permitting to investigate expression gen profile and protein mutation.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Collaborators: Merck Serono International SA; Merck Sharp & Dohme Corp.
• Treatments: Cetuximab

Criteria

Inclusion Criteria:

• More than 18 years

• Histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx

• patients selected for a primary surgical treatment

• No distant metastases

• No active second malignancy during the last 5 years

• No prior or concurrent evidence of uncontrolled severe pathology precluding administration of surgery

• life expectancy more than 3 months

• Not pregnant or nursing; fertile patients both male or female, must use effective contraception

• Signed informed consent

• Performance Status ECOG 0-1

Exclusion Criteria:

• Nasopharynx cancer

• Past or current malignancy other than HNSCC

• performance Status ECOG above 2

• Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol

• Use of any investigationals agents within 4 weeks prior ti entry

• Previous exposure to EGFR targeting therapy

• Known grade hypersensitivity to cetuximab