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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Odense University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01020864
First received: November 25, 2009
Last updated: April 6, 2011
Last verified: April 2011
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Odense University Hospital:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
  • Response rate [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
  • Median survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Correlation between response and evolvement in tumor biology markers. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 55
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: May 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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020864

Contacts
Contact: Jorgen Johansen, MD, PhD +45 6541 4568 jorgen.johansen@ouh.regionsyddanmark.dk
Contact: Per Pfeiffer, Professor, MD, PhD +45 6541 2921 per.pfeiffer@ouh.regionsyddanmark.dk

Locations
Denmark
Department of Oncology, Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Jorgen Johansen, MD, PhD    +45 6541 4568    jorgen.johansen@ouh.regionsyddanmark.dk   
Principal Investigator: Jorgen Johansen, MD, PhD         
Sponsors and Collaborators
Odense University Hospital
Investigators
Study Chair: Per Pfeiffer, Professor, MD, PhD Odense University Hospital
  More Information

No publications provided

Responsible Party: Professor Per Pfeiffer, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01020864     History of Changes
Other Study ID Numbers: 09.08
Study First Received: November 25, 2009
Last Updated: April 6, 2011
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee

Keywords provided by Odense University Hospital:
Platinum-resistent head and neck cancer
Cetuximab
Carboplatin
Navelbine
Phase II trial
Combination chemotherapy

Additional relevant MeSH terms:
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Vinorelbine
Cetuximab
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014