Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer

Not Recruiting

Trial ID: NCT00101582


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
Quynh-Thu Le, MD

Katharine Dexter McCormick and Stanley McCormick Memorial Professor and Professor, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS)

Harlan Pinto
Harlan Pinto

Associate Professor of Medicine (Oncology) and of Otolaryngology - Head & Neck Surgery


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)


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

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