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

Sponsor

Per Pfeiffer (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01020864

Collaborator

Odense University Hospital (Other)

Enrollment

Location

Arm

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Neoplasms	Drug: Cetuximab Drug: Carboplatin Drug: Vinorelbine	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chemotherapy 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.	Drug: Cetuximab Cetuximab 500 mg/m² i.v. day 1, every 2nd week Other Names: Erbitux Drug: Carboplatin Carboplatin AUC = 3 i.v. day 1, every 21nd week Drug: Vinorelbine Vinorelbine 25 mg/m² i.v. day 1, every 2nd week

Arm

Intervention/Treatment

Experimental: Chemotherapy

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.

Drug: Cetuximab

Cetuximab 500 mg/m² i.v. day 1, every 2nd week

Other Names:

Erbitux

Drug: Carboplatin

Carboplatin AUC = 3 i.v. day 1, every 21nd week

Drug: Vinorelbine

Vinorelbine 25 mg/m² i.v. day 1, every 2nd week

Outcome Measures

Primary Outcome Measures

Progression-free survival [2.5 years]
Response rate [3 years]

Secondary Outcome Measures

Toxicity [2.5 years]
Median survival [3 years]
Correlation between response and evolvement in tumor biology markers. [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.