Cetuximab in Combination With Chemotherapy for Patients With Head and Neck Cancer (CECAVI)

Per Pfeiffer

Status and phase: Withdrawn; Phase 2

Conditions: Head and Neck Neoplasms

Treatments: Drug: Vinorelbine; Drug: Carboplatin; Drug: Cetuximab

Study type: Interventional

Funder types: Other

Identifiers

NCT01020864

09.08

Details and patient eligibility

About

This is an open, multicenter phase II study. The purpose is to demonstrate the efficacy of cetuximab in combination with carboplatin and vinorelbine as second line treatment in patients with recurrent or metastatic head and neck cancer who have progressed during or after treatment with first line cisplatinum.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically verified squamous cell carcinoma of the head and neck where curatively intended local treatment is not possible.
• Measurable or non-measurable disease.
• Disease progression during or after first line palliative chemotherapy with cisplatinum or patients with recurrence < 6 months after primary concomitant chemo-radiotherapy with cisplatinum.
• WHO Performance Status 0-2.
• Age ≥ 18 years.
• Neutrophil count (ANC) ≥ 1.5 x 10^9/l and platelets ≥ 100 x 10^9/l.
• Normal liver function with bilirubin < 1.5 x UNL (Upper Normal Limit), no UNL for ALAT with liver metastases.
• Creatinin clearance ≥ 50 ml/min.
• Signed informed consent.

Exclusion criteria

• Other active malignant disease.
• Patients who are considered unable to follow the treatment plan or follow-up visits.
• Other serious disease (e.g. severe heart disease, myocardial infarction (MI) within 1 year, active infection).
• Any condition or treatment which after the opinion of the investigator may expose the patient to a risk or may influence the purpose of the trial.
• Pregnant or lactating women.
• Known hypersensitivity towards one or more of the components of the treatment.
• Prior treatment with either cetuximab or other inhibitors of EGFR.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Chemotherapy

Experimental group

Description:

Patients will be treated with Cetuximab, Carboplatin and Vinorelbine i.v. day 1, every 2nd week. Patients will be treated until progression and/or in case of unacceptable toxicity or if the patient wishes to stop treatment.

Treatment:

Drug: Vinorelbine

Drug: Cetuximab

Drug: Carboplatin