A Study of Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy and Concurrent Chemotherapy

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Oral Mucositis associated with adjuvant radiation and concurrent chemotherapy in postoperative Head and Neck setting

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swedish Orphan Biovitrum
• Collaborator: Amgen
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

• History of newly diagnosed histologically confirmed squamous cell carcinoma (American Joint Committee on Cancer [AJCC] Stage II, III, IVA, or IVB) involving either the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx, post surgical resection (R0, R1)

• Scheduled to receive adjuvant concurrent chemoradiation treatment within 12 weeks of surgery

• High-risk subject defined by presence of at least one of the following: R1 resection margins; T3 or T4 tumor stage; 3 or more positive lymph node metastases; <3 lymph node metastases with extracapsular extension of the disease

• Radiation treatment field to receive planned dose of at least 50Gy to areas of the oral cavity/oropharynx mucosa that can be visualized

Exclusion Criteria:

• Tumors of the lips, paranasal sinuses, salivary glands, or of unknown primary tumors

• Metastatic disease (M1) / Stage IV C

• Presence or history of any other primary malignancy

• History of pancreatitis

• Prior radiotherapy to the site of disease

• Prior chemotherapy

• Other investigational procedures

• Thirty days or less since receiving an investigational product or device in another clinical trial. Current enrollment in another clinical trial is not permitted unless the sole purpose of the trial is for long-term follow-up/survival data