NCT00626639 - A Study of Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy and Concurrent Chemotherapy | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 31, 2005

Primary Completion Date

May 31, 2007

Study Completion Date

July 31, 2015

Conditions

MucositisHead and Neck Cancer

Interventions

DRUG

Placebo

Administered by intravenous (IV) bolus injection

DRUG

palifermin

Administered by intravenous (IV) bolus injection

RADIATION

Radiotherapy

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 \[one fraction per day\])

DRUG

Cisplatin

100 mg/m\^2 intravenously (IV) on days 1, 22 and 43.