Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

188

Participants

Timeline

Start Date

August 31, 2005

Primary Completion Date

September 30, 2007

Study Completion Date

August 31, 2016

Conditions
MucositisSolid TumorsStomatitisHead and Neck CancerSquamous Cell Carcinoma
Interventions
DRUG

Placebo

DRUG

palifermin

DRUG

cisplatin chemotherapy

Commercially available cisplatin was administered as an intravenous infusion at a dose of 100 mg/m\^2 on Days 1, 22, and 43.

RADIATION

Radiotherapy

Radiotherapy was delivered in 200 cGy daily fractions, 5 days a week.

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

lead

Swedish Orphan Biovitrum

INDUSTRY