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

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01020864

Acronym

CECAVI

Enrollment

Registered

2009-11-26

Start date

2010-01-31

Completion date

2012-01-31

Last updated

2020-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Neoplasms

Keywords

Platinum-resistent head and neck cancer, Cetuximab, Carboplatin, Navelbine, Phase II trial, Combination chemotherapy

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.

Interventions

DRUGCetuximab

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

DRUGCarboplatin

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

DRUGVinorelbine

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame
Progression-free survival	2.5 years
Response rate	3 years

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026