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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00131638
First received: July 26, 2005
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Head and Neck Cancer
Drug: Placebo
Drug: Palifermin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Incidence percentage of severe oral mucositis (Grades 3 or 4 on the WHO oral mucositis scale) [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Time to onset of severe oral mucositis (WHO Grades 3 or 4) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Total dose of opioid analgesics used (mg of morphine equivalents) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Incidence of unplanned delays in CT for cisplatin administration on Day 22 (to include discontinuations of CT) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Incidence of xerostomia (CTCAE v3.0 Dry Mouth/Xerostomia scale Grade 2 or higher) [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Duration of severe oral mucositis (WHO Grades 3 or 4) [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • Incidence of >/equal to 5 missed consecutive fractions of scheduled RT (to include discontinuations of RT) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 241
Study Start Date: January 2005
Estimated Study Completion Date: June 2017
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131638

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00131638     History of Changes
Other Study ID Numbers: 20040118
Study First Received: July 26, 2005
Last Updated: October 23, 2013
Health Authority: Austria: Bundesamt für Sicherheit im Gesundheitswesen
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Australia: Therapeutic Goods Administration

Keywords provided by Amgen:
Oncology
KGF
Palifermin
Oral mucositis
Clinical Trial
Amgen
head and neck

Additional relevant MeSH terms:
Head and Neck Neoplasms
Stomatitis
Mucositis
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 26, 2014