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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 25, 2009

Last Updated Date

April 6, 2011

Start Date ^ICMJE

January 2010

Estimated Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01020864 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Cetuximab in Combination With Chemotherapy for Patients With Head and Neck Cancer

Official Title ^ICMJE

Phase II Trial of Cetuximab in Combination With Chemotherapy (Carboplatin and Navelbine) for Patients With Platinum-resistant Head and Neck Cancer

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Head and Neck Neoplasms

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2012

Estimated Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01020864

Other Study ID Numbers ^ICMJE

09.08

Has Data Monitoring Committee

Yes

Responsible Party

Professor Per Pfeiffer, Odense University Hospital

Study Sponsor ^ICMJE

Odense University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Per Pfeiffer, Professor, MD, PhD

Odense University Hospital

Information Provided By

Odense University Hospital

Verification Date

April 2011

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

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