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

Head and Neck Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00131638
• Other study ID #: 20040118
• Status: Completed
• Phase: Phase 3
• First received: July 26, 2005
• Last updated: December 14, 2016
• Start date: January 2005
• Est. completion date: July 2016

Study information

• Verified date: December 2016
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Bundesamt für Sicherheit im GesundheitswesenCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesSpain: Agencia Española de Medicamentos y Productos SanitariosUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug AdministrationAustralia: Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: July 2016
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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-

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Mucositis
• Stomatitis

Intervention

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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence percentage of severe oral mucositis (Grades 3 or 4 on the WHO oral mucositis scale)		Up to 24 weeks	No
Secondary	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]		16 weeks	No
Secondary	Time to onset of severe oral mucositis (WHO Grades 3 or 4)		12 weeks	No
Secondary	Total dose of opioid analgesics used (mg of morphine equivalents)		16 weeks	No
Secondary	Incidence of unplanned delays in CT for cisplatin administration on Day 22 (to include discontinuations of CT)		12 weeks	No
Secondary	Incidence of xerostomia (CTCAE v3.0 Dry Mouth/Xerostomia scale Grade 2 or higher)		10 years	No
Secondary	Duration of severe oral mucositis (WHO Grades 3 or 4)		15 weeks	No
Secondary	Incidence of >/equal to 5 missed consecutive fractions of scheduled RT (to include discontinuations of RT)		12 weeks	No

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling