Status:
COMPLETED
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer
Lead Sponsor:
Amgen
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of palifermin (recombinant human keratinocyte growth factor, rHuKGF) in reducing the incidence of severe oral mucositis in subjects wit...
Detailed Description
This study is being conducted to evaluate the efficacy of palifermin administered intravenously (IV) in weekly doses (minimum of 7 weekly doses, until RT was complete) in reducing the incidence of sev...
Eligibility Criteria
Inclusion
- History of histologically documented squamous cell carcinoma ( AJCC \[American Joint Committee on Cancer\] Stage II, III, IVA or IVB) involving either the oral cavity, oropharynx, hypopharynx, or larynx,post surgical resection (R0, R1) and candidates for adjuvant RT/CT
- Radiation treatment field to receive planned dose of at least 50Gy to area of the oral cavity/oropharynx mucosa that can be visualized
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- Functional hematopoietic and hepato-renal systems
Exclusion
- Tumors of the lips, paranasal sinuses, salivary glands, or unknown primary tumors
- Metastatic disease (M1) Stage IV C
- Presence or history of any other primary malignancy (other than curatively treated in situ cervical cancer or basal cell carcinoma of the skin)
- History of chronic pancreatitis or episode of acute pancreatitis within the last year
- Prior radiation to the site of the disease, or prior chemotherapy-
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT00131638
Start Date
January 1 2005
End Date
July 1 2016
Last Update
December 16 2016
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