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Trial record 7 of 1195 for:    Recruiting, Not yet recruiting, Available Studies | "Head and Neck Neoplasms"

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

This study is currently recruiting participants.
Verified January 2015 by Per Pfeiffer, Odense University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01020864
First Posted: November 26, 2009
Last Update Posted: January 21, 2015
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Per Pfeiffer, Odense University Hospital
  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
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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
Per Pfeiffer
Odense University Hospital
Investigators
Study Chair: Per Pfeiffer, Professor, MD, PhD Odense University Hospital
  More Information

Responsible Party: Per Pfeiffer, Professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01020864     History of Changes
Other Study ID Numbers: 09.08
First Submitted: November 25, 2009
First Posted: November 26, 2009
Last Update Posted: January 21, 2015
Last Verified: January 2015

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

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