Clinical trial NCT00131638: A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer
Official title: Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Weekly Doses of Palifermin (rHuKGF) for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer Receiving Adjuvant Radiotherapy and Chemotherapy(RT/CT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Head and Neck Cancer
Keywords: Oncology
KGF
Palifermin
Oral mucositis
Clinical Trial
Amgen
head and neck
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-08-19
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of palifermin (recombinant human keratinocyte growth factor, rHuKGF) in reducing the incidence of severe oral mucositis in subjects with locally advanced head and neck cancer receiving radiotherapy with concurrent chemotherapy as adjuvant treatment for their disease.

Detailed description: This study is being conducted to evaluate the efficacy of palifermin administered intravenously (IV) in weekly doses (minimum of 7 weekly doses, until RT was complete) in reducing the incidence of severe (World Health Organization \[WHO\] grade 3 or 4) oral mucositis in subjects with locally advanced HNC receiving RT concurrent with CT (RT/CT) as adjuvant treatment for their disease (postoperative setting). This study will assess the safety and tolerability of palifermin at the dose of 120 μg/kg IV administered weekly (minimum 7 weekly doses, until RT was complete) in this subject population. This study will also evaluate the effect of palifermin on the clinical sequelae of severe OM (eg, average subject-reported mouth and throat soreness \[MTS\] score), and on RT-induced xerostomia in this population, as well as the long-term effects of palifermin on disease outcome and survival in this population.

Eligibility criteria: Inclusion Criteria:

* History of histologically documented squamous cell carcinoma ( AJCC \[American Joint Committee on Cancer\] Stage II, III, IVA or IVB) involving either the oral cavity, oropharynx, hypopharynx, or larynx,post surgical resection (R0, R1) and candidates for adjuvant RT/CT
* Radiation treatment field to receive planned dose of at least 50Gy to area of the oral cavity/oropharynx mucosa that can be visualized
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
* Functional hematopoietic and hepato-renal systems

Exclusion Criteria:

* Tumors of the lips, paranasal sinuses, salivary glands, or unknown primary tumors
* Metastatic disease (M1) Stage IV C
* Presence or history of any other primary malignancy (other than curatively treated in situ cervical cancer or basal cell carcinoma of the skin)
* History of chronic pancreatitis or episode of acute pancreatitis within the last year
* Prior radiation to the site of the disease, or prior chemotherapy-

Primary outcomes:
measure: Incidence percentage of severe oral mucositis (Grades 3 or 4 on the WHO oral mucositis scale)
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Average patient-reported mouth and throat soreness score (as reported on Question 3 of the Oral Mucositis Weekly Questionnaire for patients with Head and Neck cancer [OMWQ-HN]
timeFrame: 16 weeks
measure: Time to onset of severe oral mucositis (WHO Grades 3 or 4)
timeFrame: 12 weeks
measure: Total dose of opioid analgesics used (mg of morphine equivalents)
timeFrame: 16 weeks
measure: Incidence of unplanned delays in CT for cisplatin administration on Day 22 (to include discontinuations of CT)
timeFrame: 12 weeks
measure: Incidence of xerostomia (CTCAE v3.0 Dry Mouth/Xerostomia scale Grade 2 or higher)
timeFrame: 10 years
measure: Duration of severe oral mucositis (WHO Grades 3 or 4)
timeFrame: 15 weeks
measure: Incidence of >/equal to 5 missed consecutive fractions of scheduled RT (to include discontinuations of RT)
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Henke M, Alfonsi M, Foa P, Giralt J, Bardet E, Cerezo L, Salzwimmer M, Lizambri R, Emmerson L, Chen MG, Berger D. Palifermin decreases severe oral mucositis of patients undergoing postoperative radiochemotherapy for head and neck cancer: a randomized, placebo-controlled trial. J Clin Oncol. 2011 Jul 10;29(20):2815-20. doi: 10.1200/JCO.2010.32.4103. Epub 2011 Jun 13.