A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer
December 14, 2016 updated by: Amgen
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
241
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Palifermin
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 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
Other Names:
|
|
Placebo Comparator: Placebo
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence percentage of severe oral mucositis (Grades 3 or 4 on the WHO oral mucositis scale)
Time Frame: Up to 24 weeks
|
Up to 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
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]
Time Frame: 16 weeks
|
16 weeks
|
|
Time to onset of severe oral mucositis (WHO Grades 3 or 4)
Time Frame: 12 weeks
|
12 weeks
|
|
Total dose of opioid analgesics used (mg of morphine equivalents)
Time Frame: 16 weeks
|
16 weeks
|
|
Incidence of unplanned delays in CT for cisplatin administration on Day 22 (to include discontinuations of CT)
Time Frame: 12 weeks
|
12 weeks
|
|
Incidence of xerostomia (CTCAE v3.0 Dry Mouth/Xerostomia scale Grade 2 or higher)
Time Frame: 10 years
|
10 years
|
|
Duration of severe oral mucositis (WHO Grades 3 or 4)
Time Frame: 15 weeks
|
15 weeks
|
|
Incidence of >/equal to 5 missed consecutive fractions of scheduled RT (to include discontinuations of RT)
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (Actual)
November 1, 2007
Study Completion (Actual)
July 1, 2016
Study Registration Dates
First Submitted
July 26, 2005
First Submitted That Met QC Criteria
August 17, 2005
First Posted (Estimate)
August 19, 2005
Study Record Updates
Last Update Posted (Estimate)
December 16, 2016
Last Update Submitted That Met QC Criteria
December 14, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20040118
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