NCT00401401

Brief Summary

The purpose of this study is to investigate the safety of zalutumumab in combination with chemotherapy and radiotherapy as treatment of patients with head and neck cancer

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

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

Timeline
Completed

Started Dec 2006

Geographic Reach
5 countries

7 active sites

Status
terminated

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 17, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2006

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

December 23, 2011

Completed
Last Updated

December 23, 2011

Status Verified

November 1, 2011

Enrollment Period

3.8 years

First QC Date

November 17, 2006

Results QC Date

October 7, 2011

Last Update Submit

November 21, 2011

Conditions

Head and Neck CancerSquamous Cell Cancer

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    Number of participants with at least one adverse event. All adverse events were collected during the 8 week treatment period and the following 4 weeks. Serious adverse events were collected during 3 years after the patient was allocated to the trial.

    Overall Study

Secondary Outcomes (3)

  • Overall Response

    Up to 3 years

  • Time to Response

    Up to 3 years

  • Best Overall Tumor Response

    Up to 3 years

Study Arms (4)

Zalutumumab 4 mg/kg

EXPERIMENTAL

Zalutumumab 8 weekly infusions

Drug: zalutumumabDrug: cisplatinProcedure: Radiotherapy

Zalutumumab 8 mg/kg

EXPERIMENTAL

Zalutumumab 8 weekly infusions

Drug: zalutumumabDrug: cisplatinProcedure: Radiotherapy

Zalutumumab 12 mg/kg

EXPERIMENTAL

Zalutumumab 8 weekly infusions

Drug: zalutumumabDrug: cisplatinProcedure: Radiotherapy

Zalutumumab 16 mg/kg

EXPERIMENTAL

Zalutumumab 8 weekly infusions

Drug: zalutumumabDrug: cisplatinProcedure: Radiotherapy

Interventions

zalutumumabDRUG

Eight weekly infusions

Zalutumumab 12 mg/kgZalutumumab 16 mg/kgZalutumumab 4 mg/kgZalutumumab 8 mg/kg
cisplatinDRUG

Infusions

Zalutumumab 12 mg/kgZalutumumab 16 mg/kgZalutumumab 4 mg/kgZalutumumab 8 mg/kg
RadiotherapyPROCEDURE

Daily in the treatment period

Zalutumumab 12 mg/kgZalutumumab 16 mg/kgZalutumumab 4 mg/kgZalutumumab 8 mg/kg

Eligibility Criteria

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

You may qualify if:

  • Patients with locoregionally advanced squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx

You may not qualify if:

  • Prior treatment with radiotherapy in the head and neck area
  • Prior treatment with chemotherapy
  • Prior treatment with similar drugs (e.g. EGFr antibodies, EGFr inhibitors)
  • Previous surgery with curative intent for head and neck cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Oregon Health Sciences Center

Portland, Oregon, 97239, United States

Location

St-Luc University Hospital

Brussels, Belgium

Location

University Hospital Gasthuisberg

Leuven, Belgium

Location

Centre Georges-Francois Leclerc Hospital

Dijon, France

Location

Hopital Bretonneau Clinique d'Oncologie et Radiothérapie

Tours, France

Location

Nijmegen University Hospital

Nijmegen, Netherlands

Location

Lund University Hospital

Lund, Sweden

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsNeoplasms, Squamous Cell

Interventions

zalutumumabCisplatinRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTherapeutics

Limitations and Caveats

All adverse events were collected during the 8 week treatment period and for additional 4 weeks. Serious adverse events were collected for the extended follow-up period of up to 3 years. The planned parallell group of the study was cancelled.

Results Point of Contact

Title
Eva Järlid Westerberg, VP Clinical Operations
Organization
Genmab A/S
E.Westerberg@genmab.com
+45 7020 2728

Study Officials

  • Vincent Gregoire, MD professor

    St-Luc University Hospital, Brussels, Belgium

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2006

First Posted

November 20, 2006

Study Start

December 1, 2006

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

December 23, 2011

Results First Posted

December 23, 2011

Record last verified: 2011-11

Locations

FR(2)NL(1)SE(1)BE(2)US(1)