Trials / Completed
CompletedNCT00101582
Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 188 (actual)
- Sponsor
- Swedish Orphan Biovitrum · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | |
| DRUG | palifermin | |
| DRUG | cisplatin chemotherapy | Commercially available cisplatin was administered as an intravenous infusion at a dose of 100 mg/m\^2 on Days 1, 22, and 43. |
| RADIATION | Radiotherapy | Radiotherapy was delivered in 200 cGy daily fractions, 5 days a week. |
Timeline
- Start date
- 2005-08-01
- Primary completion
- 2007-09-01
- Completion
- 2016-08-01
- First posted
- 2005-01-13
- Last updated
- 2016-09-27
- Results posted
- 2014-09-15
Source: ClinicalTrials.gov record NCT00101582. Inclusion in this directory is not an endorsement.