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| Name | Class |
|---|---|
| Clinical Trial Unit Ente Ospedaliero Cantonale | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panitumumab | Experimental | 6 mg/kg per administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panitumumab | Drug | IV administration every 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of tumor response in advanced platinum-resistant head and neck cancer | To evaluate rate of radiological tumor response in advanced platinum-resistant head and neck cancer | Radiological tumor evaluation every 8 weeks, minimum 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event according to Common Terminology Criteria for Adverse Events (CTCAE) v.3 | To collect all adverse event occurred during the treatment | Collection of adverse event for at least the first 8 weeks |
| Analysis of tumor biomarkers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michele Ghielmini, Prof | Oncology Institute of Southern Switzerland | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28592616 | Derived | Siano M, Molinari F, Martin V, Mach N, Fruh M, Freguia S, Corradino I, Ghielmini M, Frattini M, Espeli V. Multicenter Phase II Study of Panitumumab in Platinum Pretreated, Advanced Head and Neck Squamous Cell Cancer. Oncologist. 2017 Jul;22(7):782-e70. doi: 10.1634/theoncologist.2017-0069. Epub 2017 Jun 7. |
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| ID | Term |
|---|---|
| D000077544 | Panitumumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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To identify the tumor biomarkers that can best predict response to panitumumab
| 28 days (1 cycle) |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |