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Head Lice |
Lice; Lice Infestation |
Clinical Trial: Study to Evaluate Palifermin for the Reduction of Oral Mucositis in Subjects with Advanced Head and Neck Cancer
This study is currently recruiting patients.
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Purpose
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).
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Head and Neck Cancer Squamous Cell Carcinoma | Drug: Palifermin | Phase III |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Head and Neck Cancer
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Weekly Doses of Palifermin (Recombinant Human Keratinocyte Growth Factor, rHuKGF) for the Reduction of Oral Mucositis in Subjects with Advanced Head and Neck Cancer Receiving Radiotherapy With Concurrent Chemotherapy (RT/CT)
Study start: January 2005
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Key Inclusion Criteria:
- Histologically documented squamous cell carcinoma (staging supported by triple endoscopy and CT scan) involving either the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx
- Newly diagnosed, locally advanced stage HNC (unresectable/unresected disease); American Joint Committee on Cancer [AJCC] Stage III, IVA or IVB amenable to RT/CT as the definitive treatment modality
- Radiation treatment field to receive planned dose of 70 Gy
- At least 50 Gy of radiation treatment to areas of the oral cavity/oropharynx mucosa that can be visualized
- Concurrent chemotherapy regimen of 5-Fluorouracil (600 mg/m2/day continuous infusion over 96 hours) and Cisplatin (20 mg/m2/day x 4 days) during weeks 1 and 5
- 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:
- Tumors of the lips, paranasal sinuses, salivary glands, or of unknown primary
- Metastatic disease (M1)/Stage IVC
- Presence or history of any other primary malignancy
- History of pancreatitis
- Plan to remove the tumor surgically before completing the protocol RT/CT course
- Prior radiotherapy to the site of disease
- Prior chemotherapy
- Known sensitivity to any of the products administered during dosing, including E coli-derived products
- Known to be sero-positive for human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C virus (HCV)
Location and Contact Information
California
Research Site, Orange, California, United States; Recruiting
Research Site, Stanford, California, United States; Recruiting
Delaware
Research Site, Newark, Delaware, United States; Recruiting
Kentucky
Research Site, Lexington, Kentucky, United States; Recruiting
Louisiana
Research Site, Shreveport, Louisiana, United States; Recruiting
Maryland
Research Site, Baltimore, Maryland, United States; Recruiting
Research Site, Bethesda, Maryland, United States; Recruiting
Massachusetts
Research Site, Boston, Massachusetts, United States; Recruiting
New Jersey
Research Site, Hackensack, New Jersey, United States; Recruiting
Research Site, Somers Point, New Jersey, United States; Recruiting
New York
Research Site, Brooklyn, New York, United States; Recruiting
Ohio
Research Site, Sylvania, Ohio, United States; Recruiting
More Information
AmgenTrials clinical trials website
Center Watch Clinical Trials Listing Service
Record last reviewed: February 2005
Last Updated: February 14, 2005
Record first received: January 12, 2005
ClinicalTrials.gov Identifier: NCT00101582
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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