NCT01020864

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 26, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

November 2, 2020

Status Verified

October 1, 2020

Enrollment Period

2 years

First QC Date

November 25, 2009

Last Update Submit

October 29, 2020

Conditions

Head and Neck Neoplasms

Keywords

Platinum-resistent head and neck cancerCetuximabCarboplatinNavelbinePhase II trialCombination chemotherapy

Outcome Measures

Primary Outcomes (2)

  • Progression-free survival

    2.5 years

  • Response rate

    3 years

Secondary Outcomes (3)

  • Toxicity

    2.5 years

  • Median survival

    3 years

  • Correlation between response and evolvement in tumor biology markers.

    3 years

Study Arms (1)

Chemotherapy

EXPERIMENTAL

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: CetuximabDrug: CarboplatinDrug: Vinorelbine

Interventions

CetuximabDRUG

Cetuximab 500 mg/m² i.v. day 1, every 2nd week

Also known as: Erbitux
Chemotherapy
CarboplatinDRUG

Carboplatin AUC = 3 i.v. day 1, every 21nd week

Chemotherapy
VinorelbineDRUG

Vinorelbine 25 mg/m² i.v. day 1, every 2nd week

Chemotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology, Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

CetuximabCarboplatinVinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCoordination ComplexesOrganic ChemicalsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Per Pfeiffer, Professor, MD, PhD

    Odense University Hospital

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 25, 2009

First Posted

November 26, 2009

Study Start

January 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

November 2, 2020

Record last verified: 2020-10

Locations

DK(1)