Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer
Information source: Swedish Orphan Biovitrum
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mucositis; Solid Tumors; Stomatitis; Head and Neck Cancer; Squamous Cell Carcinoma
Intervention: Placebo (Drug); palifermin (Drug); cisplatin chemotherapy (Drug); Radiotherapy (Radiation)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Swedish Orphan Biovitrum Official(s) and/or principal investigator(s): MD, Study Director, Affiliation: Amgen
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).
Clinical Details
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)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Number of Participants With Severe (Grade 3 or 4) Oral Mucositis
Secondary outcome: Duration of Severe (WHO Grade 3 or 4) Oral MucositisTime to Onset of Severe (WHO Grade 3 or 4) Oral Mucositis Number of Participants With Xerostomia at Month 4 (Grade 2 or Higher) Patient-Reported Mouth and Throat Soreness Score Total Dose of Opioid Analgesics Used for Mucositis Within 15 Weeks Number of Participants With Unplanned Breaks in Cisplatin Chemotherapy Treatment Number of Participants With Unplanned Breaks in Radiotherapy
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Additional Information
Starting date: August 2005
Last updated: May 27, 2015
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