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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

November 25, 2009
April 6, 2011
January 2010
May 2012   (final data collection date for primary outcome measure)
  • Progression-free survival [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
  • Response rate [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01020864 on ClinicalTrials.gov Archive Site
  • 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 ]
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
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Interventions:
  • Drug: Cetuximab
  • Drug: Carboplatin
  • Drug: Vinorelbine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
55
December 2012
May 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.
Both
18 Years to 80 Years
No
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
Denmark
 
NCT01020864
09.08
Yes
Professor Per Pfeiffer, Odense University Hospital
Odense University Hospital
Not Provided
Study Chair: Per Pfeiffer, Professor, MD, PhD Odense University Hospital
Odense University Hospital
April 2011

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