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

Primary Purpose

Head and Neck Neoplasms

Status
Withdrawn
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Cetuximab
Carboplatin
Vinorelbine
Sponsored by
Per Pfeiffer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms focused on measuring Platinum-resistent head and neck cancer, Cetuximab, Carboplatin, Navelbine, Phase II trial, Combination chemotherapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Oncology, Odense University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chemotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Progression-free survival
Response rate

Secondary Outcome Measures

Toxicity
Median survival
Correlation between response and evolvement in tumor biology markers.

Full Information

First Posted
November 25, 2009
Last Updated
October 29, 2020
Sponsor
Per Pfeiffer
Collaborators
Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01020864
Brief Title
Cetuximab in Combination With Chemotherapy for Patients With Head and Neck Cancer
Acronym
CECAVI
Official Title
Phase II Trial of Cetuximab in Combination With Chemotherapy (Carboplatin and Navelbine) for Patients With Platinum-resistant Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Withdrawn
Study Start Date
January 2010 (Actual)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Per Pfeiffer
Collaborators
Odense University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms
Keywords
Platinum-resistent head and neck cancer, Cetuximab, Carboplatin, Navelbine, Phase II trial, Combination chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chemotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Other Intervention Name(s)
Erbitux
Intervention Description
Cetuximab 500 mg/m² i.v. day 1, every 2nd week
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin AUC = 3 i.v. day 1, every 21nd week
Intervention Type
Drug
Intervention Name(s)
Vinorelbine
Intervention Description
Vinorelbine 25 mg/m² i.v. day 1, every 2nd week
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
2.5 years
Title
Response rate
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Toxicity
Time Frame
2.5 years
Title
Median survival
Time Frame
3 years
Title
Correlation between response and evolvement in tumor biology markers.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Pfeiffer, Professor, MD, PhD
Organizational Affiliation
Odense University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Oncology, Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

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

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