Head and Neck Cancer
Conditions
Keywords
Oncology, KGF, HNC, head and neck, oral mucositis, OM, proteinurea, palifermin, clinical trial
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.
Interventions
DRUGPlacebo
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.
DRUGpalifermin
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
Sponsors
Amgen
Swedish Orphan Biovitrum
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Incidence of other malignancies | 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 |
| 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) |
Outcome results
None listed