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WithdrawnNCT01020864CECAVIUpdated Nov 2, 2020

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

A Phase 2 interventional study of Cetuximab and Carboplatin in Head and Neck Neoplasms, sponsored by Per Pfeiffer. Withdrawn at 1 site in Denmark. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-11-02.

Sponsored by Per Pfeiffer · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Head and Neck Neoplasms

Keywords

  • Platinum-resistent head and neck cancer
  • Cetuximab
  • Carboplatin
  • Navelbine
  • Phase II trial
  • Combination chemotherapy
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Per Pfeiffer is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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 · Drug: Carboplatin · Drug: Vinorelbine

Interventions

  • DrugCetuximab

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

    Also known as: Erbitux

  • DrugCarboplatin

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

  • DrugVinorelbine

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

06

What researchers measure

Primary outcomes

  1. Progression-free survival

    Time frame: 2.5 years

  2. Response rate

    Time frame: 3 years

Secondary outcomes

  1. Toxicity

    Time frame: 2.5 years

  2. Median survival

    Time frame: 3 years

  3. Correlation between response and evolvement in tumor biology markers.

    Time frame: 3 years

07

Study locations

1 site
  • Department of Oncology, Odense University Hospital
    Odense, 5000, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01020864
Lead sponsor
Per Pfeiffer
Collaborators
Odense University Hospital
Responsible party
Per Pfeiffer (Professor, Odense University Hospital) — Sponsor-investigator
First posted
Nov 26, 2009
Start date
Jan 2010
Primary completion
Jan 2012
Completion
Jan 2012
Last update
Nov 2, 2020

Study contacts

Per Pfeiffer, Professor, MD, PhD
study chair · Odense University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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