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

Sponsor:	Biovitrum
Collaborator:	Amgen
Information provided by:	Biovitrum
ClinicalTrials.gov Identifier:	NCT00540332

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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Palifermin

U.S. FDA Resources

Further study details as provided by Biovitrum:

Primary Outcome Measures:

Incidence of treatment-emergent proteinuria [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
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 ]

Secondary Outcome Measures:

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 ]
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 ]

Enrollment:	0
Study Start Date:	October 2007
Estimated Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (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

Sponsors and Collaborators

Biovitrum

Amgen

Investigators

Study Director:

MD

Biovitrum AB (publ)

More Information

Additional Information:

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

No publications provided

Responsible Party:	Biovitrum AB (publ) ( Clinical Development )
Study ID Numbers:	20070201
Study First Received:	October 4, 2007
Last Updated:	February 27, 2009
ClinicalTrials.gov Identifier:	NCT00540332 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; 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

Keywords provided by Biovitrum:

Oncology
KGF
HNC
head and neck
oral mucositis

OM
proteinurea
palifermin
clinical trial

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 November 30, 2009