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

Amgen241 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

241

Conditions

Head and Neck Cancer

Interventions

PlaceboDRUG

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.

PaliferminDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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-

Outcomes

Primary Outcomes

Incidence percentage of severe oral mucositis (Grades 3 or 4 on the WHO oral mucositis scale)

Time frame: Up to 24 weeks

Secondary Outcomes

Average patient-reported mouth and throat soreness score (as reported on Question 3 of the Oral Mucositis Weekly Questionnaire for patients with Head and Neck cancer [OMWQ-HN]

Time frame: 16 weeks

Time to onset of severe oral mucositis (WHO Grades 3 or 4)

Time frame: 12 weeks

Total dose of opioid analgesics used (mg of morphine equivalents)

Time frame: 16 weeks

Incidence of unplanned delays in CT for cisplatin administration on Day 22 (to include discontinuations of CT)

Time frame: 12 weeks

Incidence of xerostomia (CTCAE v3.0 Dry Mouth/Xerostomia scale Grade 2 or higher)

Time frame: 10 years

Duration of severe oral mucositis (WHO Grades 3 or 4)

Time frame: 15 weeks

Incidence of >/equal to 5 missed consecutive fractions of scheduled RT (to include discontinuations of RT)

Time frame: 12 weeks

Data from ClinicalTrials.gov

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