Back to resultsA Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer
Primary Purpose
Head and Neck Cancer
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Placebo
Palifermin
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring Oncology, KGF, Palifermin, Oral mucositis, Clinical Trial, Amgen, head and neck
Eligibility Criteria
Inclusion Criteria: History of histologically documented squamous cell carcinoma ( AJCC [American Joint Committee on Cancer] Stage II, III, IVA or IVB) involving either the oral cavity, oropharynx, hypopharynx, or larynx,post surgical resection (R0, R1) and candidates for adjuvant RT/CT Radiation treatment field to receive planned dose of at least 50Gy to area of the oral cavity/oropharynx mucosa that can be visualized Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 Functional hematopoietic and hepato-renal systems Exclusion Criteria: Tumors of the lips, paranasal sinuses, salivary glands, or unknown primary tumors Metastatic disease (M1) Stage IV C Presence or history of any other primary malignancy (other than curatively treated in situ cervical cancer or basal cell carcinoma of the skin) History of chronic pancreatitis or episode of acute pancreatitis within the last year Prior radiation to the site of the disease, or prior chemotherapy-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Palifermin
Placebo
Arm Description
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
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.
Outcomes
Primary Outcome Measures
Incidence percentage of severe oral mucositis (Grades 3 or 4 on the WHO oral mucositis scale)
Secondary Outcome Measures
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]
Time to onset of severe oral mucositis (WHO Grades 3 or 4)
Total dose of opioid analgesics used (mg of morphine equivalents)
Incidence of unplanned delays in CT for cisplatin administration on Day 22 (to include discontinuations of CT)
Incidence of xerostomia (CTCAE v3.0 Dry Mouth/Xerostomia scale Grade 2 or higher)
Duration of severe oral mucositis (WHO Grades 3 or 4)
Incidence of >/equal to 5 missed consecutive fractions of scheduled RT (to include discontinuations of RT)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00131638
Brief Title
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer
Official Title
Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Weekly Doses of Palifermin (rHuKGF) for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer Receiving Adjuvant Radiotherapy and Chemotherapy(RT/CT)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Oncology, KGF, Palifermin, Oral mucositis, Clinical Trial, Amgen, head and neck
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
241 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Palifermin
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Pbo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Palifermin
Other Intervention Name(s)
KGF
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence percentage of severe oral mucositis (Grades 3 or 4 on the WHO oral mucositis scale)
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
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]
Time Frame
16 weeks
Title
Time to onset of severe oral mucositis (WHO Grades 3 or 4)
Time Frame
12 weeks
Title
Total dose of opioid analgesics used (mg of morphine equivalents)
Time Frame
16 weeks
Title
Incidence of unplanned delays in CT for cisplatin administration on Day 22 (to include discontinuations of CT)
Time Frame
12 weeks
Title
Incidence of xerostomia (CTCAE v3.0 Dry Mouth/Xerostomia scale Grade 2 or higher)
Time Frame
10 years
Title
Duration of severe oral mucositis (WHO Grades 3 or 4)
Time Frame
15 weeks
Title
Incidence of >/equal to 5 missed consecutive fractions of scheduled RT (to include discontinuations of RT)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History of histologically documented squamous cell carcinoma ( AJCC [American Joint Committee on Cancer] Stage II, III, IVA or IVB) involving either the oral cavity, oropharynx, hypopharynx, or larynx,post surgical resection (R0, R1) and candidates for adjuvant RT/CT
Radiation treatment field to receive planned dose of at least 50Gy to area of the oral cavity/oropharynx mucosa that can be visualized
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Functional hematopoietic and hepato-renal systems
Exclusion Criteria:
Tumors of the lips, paranasal sinuses, salivary glands, or unknown primary tumors
Metastatic disease (M1) Stage IV C
Presence or history of any other primary malignancy (other than curatively treated in situ cervical cancer or basal cell carcinoma of the skin)
History of chronic pancreatitis or episode of acute pancreatitis within the last year
Prior radiation to the site of the disease, or prior chemotherapy-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
21670447
Citation
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.
Results Reference
background
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
URL
http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf
Description
Notice regarding posted summaries of trial results
URL
http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_24_KGF_20040118.pdf
Description
To access clinical trial results information click on this link
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A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer
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