S10PANI01: Study to Investigate the Efficacy of Panitumumab in Platinum-resistant Advanced Head and Neck Squamous Cancer
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Panitumumab 6 mg/kg per administration |
Drug: Panitumumab
IV administration every 2 weeks
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Eastern Cooperative Oncology Group (ECOG) performance status 0-2, not pregnant.
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Histologically or cytologically confirmed Squamous Cell Cancer of the Head and Neck either metastatic or recurrent, judged incurable by surgery or radiation.
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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.
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Progression after or not responding to treatment with at least one cis-platin or carboplatin containing regimen.
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Measurable disease (Response Evaluation Criteria in Solid Tumours - RECIST 1.1).
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Adequate hematological values, renal and hepatic function.
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Patients may not be receiving any other investigational agents
Exclusion Criteria:
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Platinum-naïve patients.
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Patients previously progressed after a regimen containing EGFR-inhibiting agents (as cetuximab, panitumumab, gefitinib, erlotinib), even if there was an initial response.
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Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 1 year before enrollment/randomization.
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History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest computed tomography scan.
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Known or suspected brain metastases.
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Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent
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Known hypersensitivity to panitumumab active ingredient or excipients.
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Any concomitant drugs contraindicated for use with the trial drug according to the Swissmedic approved product information - Human Immunodeficiency Virus (HIV) positive patients
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Southern Europe New Drug Organization
- Clinical Trial Unit Ente Ospedaliero Cantonale
Investigators
- Study Chair: Michele Ghielmini, Prof, Oncology Institute of Southern Switzerland
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- S10PANI01