An Open Label Single Arm Trial Investigating Zalutumumab, a Human Monoclonal Anti-EGF Receptor Antibody, in Combination With Best Supportive Care, in Patients With Non-Curable Squamous Cell Carcinoma of the Head and Neck Who Have Failed Standard Platinum-based Chemotherapy.
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer, Squamous Cell Cancer
Both
Head and Neck Cancer, Squamous Cell Cancer
Trial Information
An Open Label Single Arm Trial Investigating Zalutumumab, a Human Monoclonal Anti-EGF Receptor Antibody, in Combination With Best Supportive Care, in Patients With Non-Curable Squamous Cell Carcinoma of the Head and Neck 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 prior chemotherapy regimens
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: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
Overall survival
Outcome Time Frame:
Until death
Safety Issue:
No
Principal Investigator
Steen Lisby, MD
Investigator Role:
Study Director
Investigator Affiliation:
Genmab A/S, Bredgade 34, DK-1260 Copenhagen K, Denmark
Authority:
United States: Food and Drug Administration
Study ID:
GEN205
NCT ID:
NCT00542308
Start Date:
January 2008
Completion Date:
August 2011
Related Keywords:
- Head and Neck Cancer
- Squamous Cell Cancer
- Carcinoma, Squamous Cell
- Neoplasms, Squamous Cell
- Head and Neck Neoplasms
Name | Location |
|---|---|
| Mountain States Tumor Institute | Boise, Idaho 83712 |
| Baylor University Medical Center | Dallas, Texas 75246 |
| Loma Linda University Cancer Institute | Loma Linda, California 92354 |
| University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
| Henry Ford Health Systems | Detroit, Michigan 48202 |
| University of Chicago Medical Center | Chicago, Illinois 60637 |
| Moffitt Cancer Center | Tampa, Florida 33612 |
| Oregon Health and Science University | Portland, Oregon 97201 |
| Ft. Wayne Medical Oncology/Hematology, Inc | Ft. Wayne, Indiana 46815 |
