Conditions: Mucositis Solid Tumors Stomatitis Head and Neck Cancer Squamous Cell Carcinoma
Keywords: SCCHN Palifermin Mucositis Oral Cavity Oropharynx Nasopharynx Hypopharynx Larynx Mouth Pain Mouth Sores Radiation Therapy Radiotherapy Radiochemotherapy Concurrent Chemotherapy Xerostomia Stomatitis Mucosa KGF rHuKGF Keratinocyte Growth Factor HNC Head and Neck Cancer Oral Mucositis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 188
Healthy volunteers: no

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).

Detailed description:
This study consisted of 2 phases. The acute oral mucositis (OM) evaluation phase includes the time from randomization to the time of severe OM (WHO Grade 3 or 4) resolution (up to Week 12 or up to Week 15 for participants whose severe OM is not resolved at Week 12). In the acute OM evaluation phase, participants were randomized to receive either a single IV dose of palifermin or placebo at 180 μg/kg, 3 days before the start of radiotherapy, plus 7 once-weekly palifermin or placebo doses at the same dose level during a 7-week radio/chemotherapy course. In the long-term follow up phase, participants are followed until death, withdrawal of consent, or loss to follow-up. The long-term follow up phase is still ongoing.

Arms:
arm 1: Participants 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. arm 2: Participants 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: intervention 1: Placebo intervention 2: palifermin intervention 3: cisplatin chemotherapy intervention 4: Radiotherapy
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Commercially available cisplatin was administered as an intravenous infusion at a dose of 100 mg/m\^2 on Days 1, 22, and 43. intervention 4: Radiotherapy was delivered in 200 cGy daily fractions, 5 days a week.

Protocol document: