A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer

Amgen

Status and phase: Completed; Phase 3

Conditions: Head and Neck Cancer

Treatments: Drug: Placebo; Drug: Palifermin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00131638

20040118

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of palifermin (recombinant human keratinocyte growth factor, rHuKGF) in reducing the incidence of severe oral mucositis in subjects with locally advanced head and neck cancer receiving radiotherapy with concurrent chemotherapy as adjuvant treatment for their disease.

Full description

This study is being conducted to evaluate the efficacy of palifermin administered intravenously (IV) in weekly doses (minimum of 7 weekly doses, until RT was complete) in reducing the incidence of severe (World Health Organization [WHO] grade 3 or 4) oral mucositis in subjects with locally advanced HNC receiving RT concurrent with CT (RT/CT) as adjuvant treatment for their disease (postoperative setting). This study will assess the safety and tolerability of palifermin at the dose of 120 μg/kg IV administered weekly (minimum 7 weekly doses, until RT was complete) in this subject population. This study will also evaluate the effect of palifermin on the clinical sequelae of severe OM (eg, average subject-reported mouth and throat soreness [MTS] score), and on RT-induced xerostomia in this population, as well as the long-term effects of palifermin on disease outcome and survival in this population.

Enrollment: 241 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of histologically documented squamous cell carcinoma ( AJCC [American Joint Committee on Cancer] Stage II, III, IVA or IVB) involving either the oral cavity, oropharynx, hypopharynx, or larynx,post surgical resection (R0, R1) and candidates for adjuvant RT/CT
• Radiation treatment field to receive planned dose of at least 50Gy to area of the oral cavity/oropharynx mucosa that can be visualized
• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
• Functional hematopoietic and hepato-renal systems

Exclusion criteria

• Tumors of the lips, paranasal sinuses, salivary glands, or unknown primary tumors
• Metastatic disease (M1) Stage IV C
• Presence or history of any other primary malignancy (other than curatively treated in situ cervical cancer or basal cell carcinoma of the skin)
• History of chronic pancreatitis or episode of acute pancreatitis within the last year
• Prior radiation to the site of the disease, or prior chemotherapy-

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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241 participants in 2 patient groups, including a placebo group

Palifermin

Experimental group

Description:

Single IV dose of palifermin at 120 μg/kg, 3 days before the start of radiotherapy plus 6 once weekly palifermin doses at the same dose level during a 6-week Radiotherapy / chemotherapy course

Treatment:

Drug: Palifermin

Placebo

Placebo Comparator group

Description:

Single IV dose of placebo at 120 μg/kg, 3 days before the start of Radiotherapy, plus 6 once weekly placebo doses at the same dose during a 6-week radiotherapy / chemotherapy course.

Treatment:

Drug: Placebo