Clinical trial NCT00540332: A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Head and Neck Cancer
Keywords: Oncology
KGF
HNC
head and neck
oral mucositis
OM
proteinurea
palifermin
clinical trial
Lead sponsor: Swedish Orphan Biovitrum
Sponsor class: INDUSTRY
Collaborators: name: Amgen
First posted: 2007-10-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Incidence of treatment-emergent proteinuria
timeFrame: 11 weeks
measure: Duration of treatment-emergent proteinuria
timeFrame: 11 weeks
measure: Incidence of chronic proteinuria
timeFrame: 11 weeks
measure: Time (days) to onset of treatment-emergent proteinuria
timeFrame: 11 weeks
measure: Maximum protein-to-creatinine ratio values during the treatment period
timeFrame: 11 weeks
measure: 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
timeFrame: in Week 1
Secondary outcomes:
measure: Time (days) to onset of severe Oral Mucositis WHO grade 3 or 4
timeFrame: 11 weeks
measure: Disease status at End of Treatment visit
timeFrame: 11 weeks
measure: Incidence of serum anti-palifermin antibody formation
timeFrame: 11 weeks
measure: Incidence of second primary tumors
timeFrame: up to 10 years (Long-Term Follow-Up phase)
measure: Incidence of other malignancies
timeFrame: up to 10 years (Long-Term Follow-Up phase)
measure: Progression-free survival
timeFrame: up to 10 years (Long-Term Follow-Up phase)
measure: Overall survival
timeFrame: up to 10 years (Long-Term Follow-Up phase)
measure: Incidence of adverse events and laboratory abnormalities
timeFrame: 11 weeks
measure: Incidence (%) and duration (days) of severe Oral Mucositis WHO grade 3 or 4
timeFrame: 11 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Biovitrum AB (publ)
name: MD
role: STUDY_DIRECTOR
References: