Cetuximab in Combination With Chemotherapy for Patients With Head and Neck Cancer

Head and Neck Neoplasms Clinical Trial

— CECAVI  

Official title:

Phase II Trial of Cetuximab in Combination With Chemotherapy (Carboplatin and Navelbine) for Patients With Platinum-resistant Head and Neck Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01020864
• Other study ID #: 09.08
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 2010
• Est. completion date: January 2012

Study information

• Verified date: October 2020
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

Drug:
• Cetuximab
Cetuximab 500 mg/m² i.v. day 1, every 2nd week
• Carboplatin
Carboplatin AUC = 3 i.v. day 1, every 21nd week
• Vinorelbine
Vinorelbine 25 mg/m² i.v. day 1, every 2nd week

Locations

Country	Name	City	State
Denmark	Department of Oncology, Odense University Hospital	Odense

Sponsors (2)

Lead Sponsor	Collaborator
Per Pfeiffer	Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		2.5 years
Primary	Response rate		3 years
Secondary	Toxicity		2.5 years
Secondary	Median survival		3 years
Secondary	Correlation between response and evolvement in tumor biology markers.		3 years