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

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2015 by Per Pfeiffer, Odense University Hospital
Odense University Hospital
Information provided by (Responsible Party):
Per Pfeiffer, Odense University Hospital Identifier:
First received: November 25, 2009
Last updated: January 20, 2015
Last verified: January 2015
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.

Condition Intervention Phase
Head and Neck Neoplasms Drug: Cetuximab Drug: Carboplatin Drug: Vinorelbine Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Cetuximab in Combination With Chemotherapy (Carboplatin and Navelbine) for Patients With Platinum-resistant Head and Neck Cancer

Resource links provided by NLM:

Further study details as provided by Per Pfeiffer, Odense University Hospital:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 2.5 years ]
  • Response rate [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 55
Study Start Date: January 2010
Estimated Study Completion Date: January 2018
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01020864

Contact: Jorgen Johansen, MD, PhD +45 6541 4568
Contact: Per Pfeiffer, Professor, MD, PhD +45 6541 2921

Department of Oncology, Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Jorgen Johansen, MD, PhD    +45 6541 4568   
Principal Investigator: Jorgen Johansen, MD, PhD         
Sponsors and Collaborators
Per Pfeiffer
Odense University Hospital
Study Chair: Per Pfeiffer, Professor, MD, PhD Odense University Hospital
  More Information

Responsible Party: Per Pfeiffer, Professor, Odense University Hospital Identifier: NCT01020864     History of Changes
Other Study ID Numbers: 09.08
Study First Received: November 25, 2009
Last Updated: January 20, 2015

Keywords provided by Per Pfeiffer, Odense University Hospital:
Platinum-resistent head and neck cancer
Phase II trial
Combination chemotherapy

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents
Antineoplastic Agents, Phytogenic processed this record on September 21, 2017