NCT00714649

Brief Summary

Primary diagnose HNSCC carcinoma patients eligible for curative surgery will be proposed the addition of 2 or 3 neoadjuvant cetuximab infusions. The main objective is to reduce to a minimal delay the time elapsing between last infusion and surgery. Iterative biomarkers will be taken at 6 time points permitting to investigate expression gen profile and protein mutation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P50-P75 for phase_1 head-and-neck-cancer

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2008

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

November 14, 2012

Status Verified

November 1, 2012

Enrollment Period

2.8 years

First QC Date

July 8, 2008

Last Update Submit

November 13, 2012

Conditions

Head and Neck Cancer

Keywords

Head and Neck Squamous Cell Carcinoma treated with surgeryand/or radiotherapy

Outcome Measures

Primary Outcomes (1)

  • To investigate the safety administration of cetuximab - Phase 1: to determine the safe minimum delay between preoperative cetuximab infusion and surgery -Phase II: to investigate the safety of the minimum delay determined in the phase I part.

    10 weeks

Secondary Outcomes (3)

  • To investigate the safety of postoperative radiation therapy in combination with cetuximab

    10 weeks

  • To investigate the efficacy of cetuximab monotherapy in the pre-operative setting, using FDG-PET and PET/CT scan.

    10 weeks

  • To perform translational research

    10 weeks

Study Arms (1)

I-1

OTHER

This is a phase I/II trial. PhaseI: The delay between the last administration of cetuximab and surgery will be progressively reduced. Five delay schedules are pre-defined before final administration of 3 preoperative doses of cetuximab with a 24-hour delay between the last dose of cetuximab and surgery. The cohort size is 3 patients per delay schedule, extended to 6 patients if one "limiting toxicity" is observed. Phase II: will proceed if delay schedule V is safe. The patients included in delay schedule V of the Phase I part of the study will be involved in the phase II analysis. Recruitment of a total of 12 patients (3-6 of delay schedule V in phase I plus an additional 3-9 patients).

Drug: cetuximab

Interventions

cetuximabDRUG

Cetuximab 250mg/m²/week IV before surgery till surgery

I-1

Eligibility Criteria

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

You may qualify if:

  • More than 18 years
  • Histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
  • patients selected for a primary surgical treatment
  • No distant metastases
  • No active second malignancy during the last 5 years
  • No prior or concurrent evidence of uncontrolled severe pathology precluding administration of surgery
  • life expectancy more than 3 months
  • Not pregnant or nursing; fertile patients both male or female, must use effective contraception
  • Signed informed consent
  • Performance Status ECOG 0-1

You may not qualify if:

  • Nasopharynx cancer
  • Past or current malignancy other than HNSCC
  • performance Status ECOG above 2
  • Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
  • Use of any investigationals agents within 4 weeks prior ti entry
  • Previous exposure to EGFR targeting therapy
  • Known grade hypersensitivity to cetuximab

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires St Luc-UCL

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Jean-Pascal H Machiels, MD PhD

    Cliniques Universitaires St Luc-UCL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2008

First Posted

July 14, 2008

Study Start

July 1, 2008

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

November 14, 2012

Record last verified: 2012-11

Locations

BE(1)