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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01020864
Recruitment Status : Unknown
Verified January 2015 by Per Pfeiffer, Odense University Hospital.
Recruitment status was:  Recruiting
First Posted : November 26, 2009
Last Update Posted : January 21, 2015
Odense University Hospital
Information provided by (Responsible Party):
Per Pfeiffer, Odense University Hospital

November 25, 2009
November 26, 2009
January 21, 2015
January 2010
September 2012   (Final data collection date for primary outcome measure)
  • Progression-free survival [ Time Frame: 2.5 years ]
  • Response rate [ Time Frame: 3 years ]
Same as current
Complete list of historical versions of study NCT01020864 on Archive Site
  • Toxicity [ Time Frame: 2.5 years ]
  • Median survival [ Time Frame: 3 years ]
  • Correlation between response and evolvement in tumor biology markers. [ Time Frame: 3 years ]
Same as current
Not Provided
Not Provided
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
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.
Not Provided
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Head and Neck Neoplasms
  • Drug: Cetuximab
    Cetuximab 500 mg/m² i.v. day 1, every 2nd week
    Other Name: 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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
January 2018
September 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Per Pfeiffer, Odense University Hospital
Per Pfeiffer
Odense University Hospital
Study Chair: Per Pfeiffer, Professor, MD, PhD Odense University Hospital
Odense University Hospital
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP