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

Phase 2

Withdrawn

• Conditions: Head and Neck Neoplasms
• Interventions: Drug: Cetuximab; Drug: Carboplatin; Drug: Vinorelbine

• Registration Number: NCT01020864
• Lead Sponsor: Per Pfeiffer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-25
• Study First Submitted QC: 2009-11-25
• Study First Posted: 2009-11-26
• Study Start: 2010-01
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-29
• Last Update Posted: 2020-11-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chemotherapy	Vinorelbine	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.
Chemotherapy	Carboplatin	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.
Chemotherapy	Cetuximab	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.

Primary Outcome Measures

Name	Time	Method
Response rate	3 years
Progression-free survival	2.5 years

Secondary Outcome Measures

Name	Time	Method
Median survival	3 years
Correlation between response and evolvement in tumor biology markers.	3 years
Toxicity	2.5 years

Trial Locations

Locations (1)

Department of Oncology, Odense University Hospital; 🇩🇰 Odense, Denmark