Status:
COMPLETED
Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer
Lead Sponsor:
Swedish Orphan Biovitrum
Collaborating Sponsors:
Amgen
Conditions:
Mucositis
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 (leng...
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 Wee...
Eligibility Criteria
Inclusion
- Key
- 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
- \- 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)
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT00101582
Start Date
August 1 2005
End Date
August 1 2016
Last Update
September 27 2016
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