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

Purpose

The purpose of this study is to evaluate the efficacy, safety and tolerability of palifermin on the incidence of oral mucositis in subjects with locally advanced head and neck cancer receiving postoperative radiotherapy.

Condition	Intervention	Phase
Head and Neck Cancer	Drug: Placebo Drug: palifermin	Phase I Phase II

MedlinePlus related topics:

Cancer Head and Neck Cancer

ChemIDplus related topics:

Palifermin Fibroblast growth factor 7

U.S. FDA Resources

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

Official Title:	A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics and Preliminary Efficacy of Weekly Doses of Palifermin (Recombinant Human Keratinocyte Growth Factor, rHuKGF) for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer (HNC) Receiving Postoperative Radiotherapy

Further study details as provided by Amgen:

Primary Outcome Measures:

Duration of treatment-emergent proteinuria [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
Incidence of chronic proteinuria [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
Time (days) to onset of treatment-emergent proteinuria [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
Maximum protein-to-creatinine ratio values during the treatment period [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
Pharmacokinetic profile to include Systemic clearance, volume of distribution at steady state, estimated initial concentration, area under the conc-time curve, terminal half-life and mean residual time [ Time Frame: in Week 1 ] [ Designated as safety issue: No ]
Incidence of treatment-emergent proteinuria [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of adverse events and laboratory abnormalities [ Time Frame: 11 weeks ] [ Designated as safety issue: Yes ]
Incidence (%) and duration (days) of severe Oral Mucositis WHO grade 3 or 4 [ Time Frame: 11 weeks ] [ Designated as safety issue: Yes ]
Time (days) to onset of severe Oral Mucositis WHO grade 3 or 4 [ Time Frame: 11 weeks ] [ Designated as safety issue: Yes ]
Disease status at End of Treatment visit [ Time Frame: 11 weeks ] [ Designated as safety issue: Yes ]
Incidence of serum anti-palifermin antibody formation [ Time Frame: 11 weeks ] [ Designated as safety issue: Yes ]
Incidence of second primary tumors [ Time Frame: up to 10 years (Long-Term Follow-Up phase) ] [ Designated as safety issue: Yes ]
Incidence of other malignancies [ Time Frame: up to 10 years (Long-Term Follow-Up phase) ] [ Designated as safety issue: Yes ]
Progression-free survival [ Time Frame: up to 10 years (Long-Term Follow-Up phase) ] [ Designated as safety issue: Yes ]
Overall survival [ Time Frame: up to 10 years (Long-Term Follow-Up phase) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	October 2007
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator Approximately 17 subjects to receive palifermin. Subjects will be enrolled as follows: PK cohort will be randomized in a 3:1 ratio [palifermin: placebo] in at least 12 subjects Non-PK cohort will be randomized in a 1:1 ratio [palifermin: placebo] in up to 28 subjects.	Drug: Placebo Single IV dose of placebo, 3 days before the start of RT, then once weekly placebo doses at the same dose during a planned 6 week RT course.
Palifermin: Experimental Approximately 23 subjects to receive palifermin. Subjects will be enrolled as follows: PK cohort will be randomized in a 3:1 ratio [palifermin: placebo] in at least 12 subjects Non-PK cohort will be randomized in a 1:1 ratio [palifermin: placebo] in up to 28 subjects.	Drug: palifermin 120μg/kg, single IV, 3 days before the start of Radiotherapy (RT), then once weekly at the same dose during a planned 6-week RT course

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

History of newly diagnosed histologically confirmed squamous cell carcinoma (AJCC Stage II, III or IVA) involving either the oral cavity, oropharynx, hypopharynx, larynx and post surgical resection (R0 or R1)
Candidates for postoperative RT-only treatment and scheduled to receive RT within 12 weeks of surgery
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Urinary protein-creatinine ratio (random sample, spot PCR) ≤ 0.2 mg/mg

Exclusion Criteria:

Tumors of the lips, paranasal sinuses, salivary glands, or of unknown primary tumors and R2 resection margins
Metastatic disease (M1)
Presence or history of any other primary malignancy, other than curatively treated in situ cervical cancer, or basal cell carcinoma of the skin without evidence of disease for > 3 years
History of pancreatitis
Prior radiotherapy to the site of disease
Prior chemotherapy or requiring chemotherapy during treatment phase of study
Prior treatment with palifermin, or other fibroblast or keratinocyte growth factors

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540332

Locations


Czech Republic
	Research Site
	Brno, Czech Republic
	Research Site
	Prague 8, Czech Republic

France
	Research Site
	Angers, France

Germany
	Research Site
	Freiburg, Germany
	Research Site
	Homburg, Germany
	Research Site
	Leipzig, Germany

Sponsors and Collaborators

Amgen

Investigators


Study Director:	MD	Amgen

More Information

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

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20070201
First Received:	October 4, 2007
Last Updated:	August 21, 2008
ClinicalTrials.gov Identifier:	NCT00540332
Health Authority:	Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; United States: Food and Drug Administration; Czech Republic: Statni ustav pro kontrolu leciv; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Amgen:

KGF

HNC

head and neck

oral mucositis

OM

proteinurea

palifermin

Amgen

clinical trial

Oncology

Study placed in the following topic categories:

Mouth Diseases

Digestive System Diseases

Stomatitis

Mucositis

Gastrointestinal Diseases

Head and Neck Neoplasms

Stomatognathic Diseases

Gastroenteritis

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00540332