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

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.

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Drug: Cetuximab Drug: Carboplatin Drug: Vinorelbine Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
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
Study Start Date : January 2010
Actual Primary Completion Date : September 2012
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Per Pfeiffer, Professor, Odense University Hospital Identifier: NCT01020864     History of Changes
Other Study ID Numbers: 09.08
First Posted: November 26, 2009    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 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