Zalutumumab in Patients With Non-curable Head and Neck Cancer
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to investigate if zalutumumab in combination with Best Supportive Care (BSC) is superior to BSC in non-curable patients with head and neck cancer
Full description
This is an open parallel group trial. Patients will be randomized in a 2:1 manner to receive either treatment with zalutumumab in combination with Best Supportive Care (BSC) or BSC.
Patients randomized to treatment with zalutumumab in combination with BSC will receive weekly infusions with zalutumumab starting with a loading dose (8mg/kg) followed by weekly maintenance doses until disease progression, intercurrent illness preventing further administration, unacceptable toxicity or patient decision. After Visit 2 the patient should be evaluated for presence of skin rash prior to each infusion to allow dose titration.
Individual dose titration until the patient develops grade 2 skin rash will be applied. The maximum dose used in study will be 16 mg/kg.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Males and Females age ≥ 18 years
- Confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy
- Failure to at least one course of standard platinum-based chemotherapy
Exclusion criteria
- Three or more chemotherapy regimens other than platinum-based chemotherapy
- Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors
- Past or current malignancy other than SCCHN, except for certain other cancer diseases
Trial design
Primary purpose
Allocation
Interventional model
Masking
286 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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