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

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00131638

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 III

MedlinePlus related topics: Cancer Head and Neck Cancer Radiation Therapy

Drug Information available for: Palifermin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
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)

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: 12 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 >/equal to 5 missed consecutive fractions of scheduled RT (to include discontinuations of RT) [ Time Frame: 12 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 ]

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
Palifermin: Experimental 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
Placebo: Placebo Comparator 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.

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

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

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

To access clinical trial results information click on this link This link exits the ClinicalTrials.gov site

FDA-approved Drug Labeling This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20040118
Study First Received:	July 26, 2005
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00131638 History of Changes
Health Authority:	Austria: Bundesamt für Sicherheit im Gesundheitswesen; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency; 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

Study placed in the following topic categories:

Mouth Diseases
Digestive System Diseases
Stomatitis
Mucositis
Gastrointestinal Diseases

Head and Neck Neoplasms
Adjuvants, Immunologic
Stomatognathic Diseases
Gastroenteritis

Additional relevant MeSH terms:

Mouth Diseases
Neoplasms
Digestive System Diseases
Neoplasms by Site
Stomatitis

Mucositis
Gastrointestinal Diseases
Head and Neck Neoplasms
Stomatognathic Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on May 06, 2009