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

NCT00540332 | Withdrawn Phase 1

• 1 other identifier: 20070201
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Head and Neck Cancer

Keywords

Oncology; KGF; HNC; head and neck; oral mucositis; OM; proteinurea; palifermin; clinical trial

Outcome Measures

Primary Outcomes (6)

• Incidence of treatment-emergent proteinuria

  11 weeks

• Duration of treatment-emergent proteinuria

  11 weeks

• Incidence of chronic proteinuria

  11 weeks

• Time (days) to onset of treatment-emergent proteinuria

  11 weeks

• Maximum protein-to-creatinine ratio values during the treatment period

  11 weeks

• 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

Secondary Outcomes (9)

• Time (days) to onset of severe Oral Mucositis WHO grade 3 or 4

  11 weeks

• Disease status at End of Treatment visit

  11 weeks

• Incidence of serum anti-palifermin antibody formation

  11 weeks

• Incidence of second primary tumors

  up to 10 years (Long-Term Follow-Up phase)

• Incidence of other malignancies

  up to 10 years (Long-Term Follow-Up phase)

Study Arms (2)

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

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

Interventions

Placebo DRUG

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.

Placebo

palifermin DRUG

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

Palifermin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swedish Orphan Biovitrum: lead
• Amgen: collaborator

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Head and Neck Neoplasms; Neoplasms; Stomatitis

Interventions

Fibroblast Growth Factor 7

Condition Hierarchy (Ancestors)

Neoplasms by Site; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fibroblast Growth Factors; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• MD

  Biovitrum AB (publ)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 4, 2007
• First Posted: October 8, 2007
• Study Start: October 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: March 2, 2009

Record last verified: 2009-01