A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy
- Registration Number
- NCT00540332
- Lead Sponsor
- Swedish Orphan Biovitrum
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 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. Palifermin palifermin 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Time (days) to onset of severe Oral Mucositis WHO grade 3 or 4 11 weeks Incidence of other malignancies up to 10 years (Long-Term Follow-Up phase) 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) Progression-free survival up to 10 years (Long-Term Follow-Up phase) Overall survival up to 10 years (Long-Term Follow-Up phase) Incidence of adverse events and laboratory abnormalities 11 weeks Incidence (%) and duration (days) of severe Oral Mucositis WHO grade 3 or 4 11 weeks