Trial Search Results

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

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).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Swedish Orphan Biovitrum

Collaborator: Amgen

Stanford Investigator(s):

Intervention(s):

  • Drug: Placebo
  • Drug: palifermin
  • Drug: cisplatin chemotherapy
  • Radiation: Radiotherapy

Phase:

Phase 3

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)

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting