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

Last updated: August 19, 2016
Sponsor: Swedish Orphan Biovitrum
Overall Status: Completed

Phase

3

Condition

Head And Neck Cancer

Squamous Cell Carcinoma

Mucositis

Treatment

N/A

Clinical Study ID

NCT00101582
20020402
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

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/unresecteddisease); American Joint Committee on Cancer [AJCC] Stage III, IVA or IVB amenable toradiotherapy with concurrent chemotherapy as the definitive treatment modality

  • At least 50 Gray of radiation treatment to areas of the oral cavity/oropharynx mucosathat 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 equalto 2

  • Adequate hematologic, renal and hepatic function

  • Negative pregnancy test by serum or urine

  • Signed informed consent

Exclusion

Key Exclusion Criteria:

  • Presence or history of any other primary malignancy (other than curatively treated insitu cervical cancer, or basal cell carcinoma of the skin without evidence of disease forgreater than 3 years)

Study Design

Total Participants: 188
Study Start date:
August 01, 2005
Estimated Completion Date:
August 31, 2016

Study Description

This study consisted of 2 phases. The acute oral mucositis (OM) evaluation phase includes the time from randomization to the time of severe OM (WHO Grade 3 or 4) resolution (up to Week 12 or up to Week 15 for participants whose severe OM is not resolved at Week 12). In the acute OM evaluation phase, participants were randomized to receive either a single IV dose of palifermin or placebo at 180 μg/kg, 3 days before the start of radiotherapy, plus 7 once-weekly palifermin or placebo doses at the same dose level during a 7-week radio/chemotherapy course. In the long-term follow up phase, participants are followed until death, withdrawal of consent, or loss to follow-up. The long-term follow up phase is still ongoing.