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An Open-labeled Trial With a Dose-escalation Part and a Parallel Group Design(1) Investigating Zalutumumab, an Anti-EGF Receptor Antibody, in Combination With Chemo-Radiation as First Line Treatment of Patients With Cancer of the Head and Neck (1) The Parallel Group Part Was Cancelled


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer, Squamous Cell Cancer

Thank you

Trial Information

An Open-labeled Trial With a Dose-escalation Part and a Parallel Group Design(1) Investigating Zalutumumab, an Anti-EGF Receptor Antibody, in Combination With Chemo-Radiation as First Line Treatment of Patients With Cancer of the Head and Neck (1) The Parallel Group Part Was Cancelled


Inclusion Criteria:



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

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse Events

Outcome Description:

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.

Outcome Time Frame:

Overall Study

Safety Issue:

Yes

Principal Investigator

Vincent Gregoire, MD professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

St-Luc University Hospital, Brussels, Belgium

Authority:

United States: Food and Drug Administration

Study ID:

Hx-EGFr-203

NCT ID:

NCT00401401

Start Date:

December 2006

Completion Date:

October 2010

Related Keywords:

  • Head and Neck Cancer
  • Squamous Cell Cancer
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms

Name

Location
Oregon Health Sciences Center Portland, Oregon  97239