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Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer
Not Recruiting
Trial ID: NCT00101582
Purpose
The purpose of this research study is to test the safety and effectiveness of palifermin to
determine if weekly doses can be safely administered to reduce the incidence (occurrence of),
duration (length of time) and severity (amount of pain) of oral mucositis (painful sores in
the mouth). Mucositis is a common side effect for patients receiving chemotherapy
(cancer-killing drug) and radiotherapy (cancer-killing x-rays) for the treatment of head and
neck cancer (HNC).
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 Radiotherapy With Concurrent Chemotherapy (RT/CT)
Stanford Investigator(s)
Quynh-Thu Le, MD
Katharine Dexter McCormick and Stanley McCormick Memorial Professor and Professor, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS)
Harlan Pinto
Associate Professor of Medicine (Oncology) and of Otolaryngology - Head & Neck Surgery
Eligibility
Key Inclusion Criteria:
- Histologically documented squamous cell carcinoma involving either the oral cavity,
oropharynx, nasopharynx, hypopharynx, or larynx
- Newly diagnosed, locally advanced stage head and neck cancer (unresectable/unresected
disease); American Joint Committee on Cancer [AJCC] Stage III, IVA or IVB amenable to
radiotherapy with concurrent chemotherapy as the definitive treatment modality
- At least 50 Gray of radiation treatment to areas of the oral cavity/oropharynx mucosa
that can be visualized
- Concurrent chemotherapy regimen of Cisplatin 100mg/m^2 on days 1, 22, and 43
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) less than or equal
to 2
- Adequate hematologic, renal and hepatic function
- Negative pregnancy test by serum or urine
- Signed informed consent
Key Exclusion Criteria:
- 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
greater than 3 years)
Intervention(s):
drug: Placebo
drug: Palifermin
drug: cisplatin chemotherapy
radiation: Radiotherapy
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061