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

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Head and Neck Cancer	Drug: Placebo; Drug: Palifermin	Phase 3

Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	241 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Weekly Doses of Palifermin (rHuKGF) for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer Receiving Adjuvant Radiotherapy and Chemotherapy(RT/CT)
Study Start Date :	January 2005
Actual Primary Completion Date :	November 2007
Actual Study Completion Date :	July 2016

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Palifermin; 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	Drug: Palifermin; 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; Other Name: KGF
Placebo Comparator: Placebo; 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.	Drug: Placebo; 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.; Other Name: Pbo

Outcome Measures

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Primary Outcome Measures :

1. Incidence percentage of severe oral mucositis (Grades 3 or 4 on the WHO oral mucositis scale) [ Time Frame: Up to 24 weeks ]

Secondary Outcome Measures :

1. 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 ]
2. Time to onset of severe oral mucositis (WHO Grades 3 or 4) [ Time Frame: 12 weeks ]
3. Total dose of opioid analgesics used (mg of morphine equivalents) [ Time Frame: 16 weeks ]
4. Incidence of unplanned delays in CT for cisplatin administration on Day 22 (to include discontinuations of CT) [ Time Frame: 12 weeks ]
5. Incidence of xerostomia (CTCAE v3.0 Dry Mouth/Xerostomia scale Grade 2 or higher) [ Time Frame: 10 years ]
6. Duration of severe oral mucositis (WHO Grades 3 or 4) [ Time Frame: 15 weeks ]
7. Incidence of >/equal to 5 missed consecutive fractions of scheduled RT (to include discontinuations of RT) [ Time Frame: 12 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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-

Contacts and Locations

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Sponsors and Collaborators

Amgen

Investigators

Study Director:	MD	Amgen

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

AmgenTrials clinical trials website 

FDA-approved Drug Labeling 

Publications:

Henke M, Alfonsi M, Foa P, Giralt J, Bardet E, Cerezo L, Salzwimmer M, Lizambri R, Emmerson L, Chen MG, Berger D. Palifermin decreases severe oral mucositis of patients undergoing postoperative radiochemotherapy for head and neck cancer: a randomized, placebo-controlled trial. J Clin Oncol. 2011 Jul 10;29(20):2815-20. doi: 10.1200/JCO.2010.32.4103. Epub 2011 Jun 13.

Responsible Party:	Amgen
ClinicalTrials.gov Identifier:	NCT00131638 History of Changes
Other Study ID Numbers:	20040118
First Posted:	August 19, 2005
Last Update Posted:	December 16, 2016
Last Verified:	December 2016

Keywords provided by Amgen:

Oncology; KGF; Palifermin; Oral mucositis	Clinical Trial; Amgen; head and neck

Additional relevant MeSH terms:

Head and Neck Neoplasms; Mucositis; Stomatitis; Neoplasms by Site; Neoplasms	Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases