Advanced Head and Neck Squamous Cancer
Conditions
Brief summary
Phase II, multicenter, open labelled, uncontrolled study to evaluate the efficacy and safety profile of panitumumab in patients affected by Head and Neck cancer after at least one cisplatin or carboplatin-based chemotherapy. A translational research study is also planned to evaluate Estimated Glomerular Filtration Rate (EGFR) status by FISH, KRAS, B-RAF, HRAS, NRAS and PIK3CA mutation by DNA sequencing, PTEN protein expression by immunohistochemistry, and Human Papilloma Virus (HPV) genotyping by reverse hybridization. Panitumumab is administered iv on days 1 and 15 of a 28 days cycle, until progressive disease, unacceptable toxicity, pregnancy, or patient's refusal
Interventions
DRUGPanitumumab
IV administration every 2 weeks
Sponsors
Clinical Trial Unit Ente Ospedaliero Cantonale
Southern Europe New Drug Organization
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2, not pregnant. * Histologically or cytologically confirmed Squamous Cell Cancer of the Head and Neck either metastatic or recurrent, judged incurable by surgery or radiation. * Baseline tumor tissue, sufficient material available for EGFR determination (therapeutic target of panitumumab) and biomarker studies. Patients without available tissue at baseline or with tissue collected longer than 1 year before, may undergo tumor biopsy. * Progression after or not responding to treatment with at least one cis-platin or carboplatin containing regimen. * Measurable disease (Response Evaluation Criteria in Solid Tumours - RECIST 1.1). * Adequate hematological values, renal and hepatic function. * Patients may not be receiving any other investigational agents
Exclusion criteria
* Platinum-naïve patients. * Patients previously progressed after a regimen containing EGFR-inhibiting agents (as cetuximab, panitumumab, gefitinib, erlotinib), even if there was an initial response. * Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 1 year before enrollment/randomization. * History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest computed tomography scan. * Known or suspected brain metastases. * Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent * Known hypersensitivity to panitumumab active ingredient or excipients. * Any concomitant drugs contraindicated for use with the trial drug according to the Swissmedic approved product information - Human Immunodeficiency Virus (HIV) positive patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of tumor response in advanced platinum-resistant head and neck cancer | Radiological tumor evaluation every 8 weeks, minimum 12 weeks | To evaluate rate of radiological tumor response in advanced platinum-resistant head and neck cancer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event according to Common Terminology Criteria for Adverse Events (CTCAE) v.3 | Collection of adverse event for at least the first 8 weeks | To collect all adverse event occurred during the treatment |
| Analysis of tumor biomarkers | 28 days (1 cycle) | To identify the tumor biomarkers that can best predict response to panitumumab |
Outcome results
None listed