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The purpose of this study is to evaluate the efficacy and safety of palifermin (recombinant human keratinocyte growth factor, rHuKGF) in reducing the incidence of severe oral mucositis in subjects with locally advanced head and neck cancer receiving radiotherapy with concurrent chemotherapy as adjuvant treatment for their disease.
This study is being conducted to evaluate the efficacy of palifermin administered intravenously (IV) in weekly doses (minimum of 7 weekly doses, until RT was complete) in reducing the incidence of severe (World Health Organization [WHO] grade 3 or 4) oral mucositis in subjects with locally advanced HNC receiving RT concurrent with CT (RT/CT) as adjuvant treatment for their disease (postoperative setting). This study will assess the safety and tolerability of palifermin at the dose of 120 μg/kg IV administered weekly (minimum 7 weekly doses, until RT was complete) in this subject population. This study will also evaluate the effect of palifermin on the clinical sequelae of severe OM (eg, average subject-reported mouth and throat soreness [MTS] score), and on RT-induced xerostomia in this population, as well as the long-term effects of palifermin on disease outcome and survival in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palifermin | Experimental | Single IV dose of palifermin at 120 μg/kg, 3 days before the start of radiotherapy plus 6 once weekly palifermin doses at the same dose level during a 6-week Radiotherapy / chemotherapy course |
|
| Placebo | Placebo Comparator | Single IV dose of placebo at 120 μg/kg, 3 days before the start of Radiotherapy, plus 6 once weekly placebo doses at the same dose during a 6-week radiotherapy / chemotherapy course. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Single IV dose of placebo at 120 μg/kg, 3 days before the start of Radiotherapy, plus 6 once weekly placebo doses at the same dose during a 6-week radiotherapy / chemotherapy course. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence percentage of severe oral mucositis (Grades 3 or 4 on the WHO oral mucositis scale) | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Average patient-reported mouth and throat soreness score (as reported on Question 3 of the Oral Mucositis Weekly Questionnaire for patients with Head and Neck cancer [OMWQ-HN] | 16 weeks | |
| Time to onset of severe oral mucositis (WHO Grades 3 or 4) | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21670447 | Background | Henke M, Alfonsi M, Foa P, Giralt J, Bardet E, Cerezo L, Salzwimmer M, Lizambri R, Emmerson L, Chen MG, Berger D. Palifermin decreases severe oral mucositis of patients undergoing postoperative radiochemotherapy for head and neck cancer: a randomized, placebo-controlled trial. J Clin Oncol. 2011 Jul 10;29(20):2815-20. doi: 10.1200/JCO.2010.32.4103. Epub 2011 Jun 13. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009369 | Neoplasms |
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D051523 | Fibroblast Growth Factor 7 |
| ID | Term |
|---|---|
| D005346 | Fibroblast Growth Factors |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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|
| Palifermin | Drug | Single IV dose of palifermin at 120 μg/kg, 3 days before the start of radiotherapy plus 6 once weekly palifermin doses at the same dose level during a 6-week Radiotherapy / chemotherapy course |
|
|
| Total dose of opioid analgesics used (mg of morphine equivalents) | 16 weeks |
| Incidence of unplanned delays in CT for cisplatin administration on Day 22 (to include discontinuations of CT) | 12 weeks |
| Incidence of xerostomia (CTCAE v3.0 Dry Mouth/Xerostomia scale Grade 2 or higher) | 10 years |
| Duration of severe oral mucositis (WHO Grades 3 or 4) | 15 weeks |
| Incidence of >/equal to 5 missed consecutive fractions of scheduled RT (to include discontinuations of RT) | 12 weeks |
| FDA-approved Drug Labeling | View source |
| D011506 | Proteins |
| D001685 | Biological Factors |