Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer
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 Radiotherapy With Concurrent Chemotherapy (RT/CT)
1 other identifier
interventional
188
0 countries
N/A
Brief Summary
The purpose of this research study is to test the safety and effectiveness of palifermin to determine if weekly doses can be safely administered to reduce the incidence (occurrence of), duration (length of time) and severity (amount of pain) of oral mucositis (painful sores in the mouth). Mucositis is a common side effect for patients receiving chemotherapy (cancer-killing drug) and radiotherapy (cancer-killing x-rays) for the treatment of head and neck cancer (HNC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2005
Longer than P75 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2005
CompletedFirst Posted
Study publicly available on registry
January 13, 2005
CompletedStudy Start
First participant enrolled
August 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedResults Posted
Study results publicly available
September 15, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedSeptember 27, 2016
August 1, 2016
2.1 years
January 12, 2005
January 3, 2014
August 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Severe (Grade 3 or 4) Oral Mucositis
Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) 2 times weekly throughout radio/chemotherapy, and 2 times weekly thereafter until severe OM returned to grade ≤ 2 or until Week 15. During each evaluation, the following anatomical areas were assessed: upper lip; lower lip; right cheek; left cheek; right ventral \& lateral tongue; left ventral \& lateral tongue; floor of the mouth; hard palate; soft palate. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.
Up to Week 15
Secondary Outcomes (7)
Duration of Severe (WHO Grade 3 or 4) Oral Mucositis
Up to 15 weeks
Time to Onset of Severe (WHO Grade 3 or 4) Oral Mucositis
Up to 15 weeks
Number of Participants With Xerostomia at Month 4 (Grade 2 or Higher)
Month 4
Patient-Reported Mouth and Throat Soreness Score
Assessed twice a week for up to 15 weeks.
Total Dose of Opioid Analgesics Used for Mucositis Within 15 Weeks
Up to 15 weeks
- +2 more secondary outcomes
Study Arms (2)
Palifermin
EXPERIMENTALParticipants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
Placebo
PLACEBO COMPARATORParticipants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
Interventions
Commercially available cisplatin was administered as an intravenous infusion at a dose of 100 mg/m\^2 on Days 1, 22, and 43.
Radiotherapy was delivered in 200 cGy daily fractions, 5 days a week.
Eligibility Criteria
You may qualify if:
- Histologically documented squamous cell carcinoma involving either the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx
- Newly diagnosed, locally advanced stage head and neck cancer (unresectable/unresected disease); American Joint Committee on Cancer \[AJCC\] Stage III, IVA or IVB amenable to radiotherapy with concurrent chemotherapy as the definitive treatment modality
- At least 50 Gray of radiation treatment to areas of the oral cavity/oropharynx mucosa that can be visualized
- Concurrent chemotherapy regimen of Cisplatin 100mg/m\^2 on days 1, 22, and 43
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) less than or equal to 2
- Adequate hematologic, renal and hepatic function
- Negative pregnancy test by serum or urine
- Signed informed consent
You may not qualify if:
- \- Presence or history of any other primary malignancy (other than curatively treated in situ cervical cancer, or basal cell carcinoma of the skin without evidence of disease for greater than 3 years)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Swedish Orphan Biovitrumlead
- Amgencollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Hans Olivecrona, MD PhD
- Organization
- Biovitrum
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2005
First Posted
January 13, 2005
Study Start
August 1, 2005
Primary Completion
September 1, 2007
Study Completion
August 1, 2016
Last Updated
September 27, 2016
Results First Posted
September 15, 2014
Record last verified: 2016-08