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)
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer
Both
Head and Neck Cancer
Trial Information
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)
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-
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Incidence percentage of severe oral mucositis (Grades 3 or 4 on the WHO oral mucositis scale)
Outcome Time Frame:
12 weeks
Safety Issue:
No
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
Austria: Bundesamt für Sicherheit im Gesundheitswesen
Study ID:
20040118
NCT ID:
NCT00131638
Start Date:
January 2005
Completion Date:
June 2017
Related Keywords:
- Head and Neck Cancer
- Oncology
- KGF
- Palifermin
- Oral mucositis
- Clinical Trial
- Amgen
- head and neck
- Head and Neck Neoplasms
- Stomatitis
- Mucositis
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