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Not Recruiting
Trial ID: NCT00101582
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)
Katharine Dexter McCormick and Stanley McCormick Memorial Professor and Professor, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS)
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
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061