Cetuximab in Combination With Chemotherapy for Patients With Head and Neck Cancer
Conditions
Head and Neck Neoplasms
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
Platinum-resistent head and neck cancer, Cetuximab, Carboplatin, Navelbine, Phase II trial, Combination chemotherapy
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Cetuximab Type: Drug
Name: Carboplatin Type: Drug
Name: Vinorelbine Type: Drug
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Location
Department of Oncology, Odense University Hospital
Odense, Denmark
Status: Recruiting
Contact: Jorgen Johansen, MD, PhD - +45 6541 4568 - jorgen.johansen@ouh.regionsyddanmark.dk
Start Date
January 2010
Completion Date
January 2018
Sponsors
Per Pfeiffer
Source
Odense University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page