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An Open-Labeled Randomized Parallel Group Trial of Zalutumumab, a Human Monoclonal Anti-EGFr Antibody, in Combination With Best Supportive Care (BSC) vs BSC, in Pts With Non-Curable SCCHN Who Have Failed Standard Platinum-Based Chemotherapy


Phase 3
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer, Squamous Cell Cancer

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Trial Information

An Open-Labeled Randomized Parallel Group Trial of Zalutumumab, a Human Monoclonal Anti-EGFr Antibody, in Combination With Best Supportive Care (BSC) vs BSC, in Pts With Non-Curable SCCHN Who Have Failed Standard Platinum-Based Chemotherapy


Inclusion Criteria:



1. Males and Females age ≥ 18 years

2. Confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oral
cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy

3. Failure to at least one course of standard platinum-based chemotherapy

Exclusion Criteria:

1. Three or more chemotherapy regimens other than platinum-based chemotherapy

2. Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors

3. Past or current malignancy other than SCCHN, except for certain other cancer diseases

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

Until death

Safety Issue:

No

Principal Investigator

.

Investigator Role:

Study Chair

Investigator Affiliation:

Dept. of Medical Oncology, Cliniques Universitaires Saint-Luc Université Catholique de Louvain, Brussels, Belgium

Authority:

Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:

Hx-EGFr-202

NCT ID:

NCT00382031

Start Date:

November 2006

Completion Date:

August 2011

Related Keywords:

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

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