Conditions: Mucositis Head and Neck Cancer
Keywords: palifermin Clinical Trial Oncology Head & Neck
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 5
Healthy volunteers: no

Brief summary:
Oral Mucositis associated with adjuvant radiation and concurrent chemotherapy in postoperative Head and Neck setting

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 bolus dose of palifermin or placebo at 120 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: Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m\^2 on days 1, 22 and 43. arm 2: Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m\^2 on days 1, 22 and 43.

Interventions: intervention 1: Placebo intervention 2: palifermin intervention 3: Radiotherapy intervention 4: Cisplatin
Intervention descriptions: intervention 1: Administered by intravenous (IV) bolus injection intervention 2: Administered by intravenous (IV) bolus injection intervention 3: Once daily irradiation of 20 centigray (cGy)/day x 33 fractions for a total target dose of 6600 cGy (conventional radiation therapy using standard fractionation \[one fraction per day\]) intervention 4: 100 mg/m\^2 intravenously (IV) on days 1, 22 and 43.

Protocol document: