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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00540332
• Other study ID #: 20070201
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: October 4, 2007
• Last updated: February 27, 2009
• Start date: October 2007
• Est. completion date: September 2008

Study information

• Verified date: January 2009
• Source: Swedish Orphan Biovitrum
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsUnited States: Food and Drug AdministrationCzech Republic: Statni ustav pro kontrolu lecivFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Other known NCT identifiers

• NCT00965159

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

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
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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Swedish Orphan Biovitrum	Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent proteinuria		11 weeks	No
Primary	Duration of treatment-emergent proteinuria		11 weeks	No
Primary	Incidence of chronic proteinuria		11 weeks	No
Primary	Time (days) to onset of treatment-emergent proteinuria		11 weeks	No
Primary	Maximum protein-to-creatinine ratio values during the treatment period		11 weeks	No
Primary	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		in Week 1	No
Secondary	Time (days) to onset of severe Oral Mucositis WHO grade 3 or 4		11 weeks	Yes
Secondary	Disease status at End of Treatment visit		11 weeks	Yes
Secondary	Incidence of serum anti-palifermin antibody formation		11 weeks	Yes
Secondary	Incidence of second primary tumors		up to 10 years (Long-Term Follow-Up phase)	Yes
Secondary	Incidence of other malignancies		up to 10 years (Long-Term Follow-Up phase)	Yes
Secondary	Progression-free survival		up to 10 years (Long-Term Follow-Up phase)	Yes
Secondary	Overall survival		up to 10 years (Long-Term Follow-Up phase)	Yes
Secondary	Incidence of adverse events and laboratory abnormalities		11 weeks	Yes
Secondary	Incidence (%) and duration (days) of severe Oral Mucositis WHO grade 3 or 4		11 weeks	Yes

External Links

•   AmgenTrials clinical trials website