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

NCT ID: NCT01020864

Last Updated: 2020-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-01-31

Brief Summary

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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

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Conditions

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Head and Neck Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cetuximab

Intervention Type DRUG

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

Carboplatin

Intervention Type DRUG

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

Vinorelbine

Intervention Type DRUG

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

Interventions

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Cetuximab

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

Intervention Type DRUG

Carboplatin

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

Intervention Type DRUG

Vinorelbine

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

Intervention Type DRUG

Other Intervention Names

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Erbitux

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role collaborator

Per Pfeiffer

OTHER

Sponsor Role lead

Responsible Party

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Per Pfeiffer

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Per Pfeiffer, Professor, MD, PhD

Role: STUDY_CHAIR

Odense University Hospital

Locations

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Department of Oncology, Odense University Hospital

Odense, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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09.08

Identifier Type: -

Identifier Source: org_study_id