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