Phase 3
N=188
Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer
Mucositis · Solid Tumors · Stomatitis · Head and Neck Cancer · Squamous Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00101582 ↗Enrolled (actual)
188
Serious AEs
32.4%
Results posted
Sep 2014
Primary outcome: Primary: Number of Participants With Severe (Grade 3 or 4) Oral Mucositis — 62; 51; 29; 43 participants — p=0.0410
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); palifermin (Drug); cisplatin chemotherapy (Drug); Radiotherapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Swedish Orphan Biovitrum
- Primary completion
- Sep 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Severe (Grade 3 or 4) Oral Mucositis |
62; 51; 29; 43; 3; 0 | 0.0410 sig |
| SECONDARY Duration of Severe (WHO Grade 3 or 4) Oral Mucositis |
26.0; 5.0 | 0.0160 sig |
| SECONDARY Time to Onset of Severe (WHO Grade 3 or 4) Oral Mucositis |
35.0; 47.0 | 0.0261 sig |
| SECONDARY Number of Participants With Xerostomia at Month 4 (Grade 2 or Higher) |
57; 37; 19; 31; 18; 26 | 0.0463 sig |
| SECONDARY Patient-Reported Mouth and Throat Soreness Score |
1.86; 1.66 | 0.0712 |
| SECONDARY Total Dose of Opioid Analgesics Used for Mucositis Within 15 Weeks |
1219.55; 1243.31 | 0.2384 |
| SECONDARY Number of Participants With Unplanned Breaks in Cisplatin Chemotherapy Treatment |
42; 49 | 0.3417 |
| SECONDARY Number of Participants With Unplanned Breaks in Radiotherapy |
11; 13 | 0.9587 |
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).
Eligibility Criteria
Key Inclusion Criteria
- 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
Key Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT00101582). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.