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Head Lice |
Lice; Lice Infestation |
Clinical Trial: A Study to Evaluate the Efficacy and Safety of Palifermin (Recombinant Human Keratinocyte Growth Factor, rHuKGF) for the Reduction of Oral Mucositis in Subjects with Advanced Head and Neck Cancer
This study is currently recruiting patients.
Verified by Amgen August 2005
|
Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Head and Neck Cancer | Drug: Palifermin | Phase III |
MedlinePlus related topics: Head and Neck Cancer
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, 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 Adjuvant Radiotherapy and Chemotherapy (RT/CT)
Study start: January 2005
Last follow-up: December 2006
Eligibility
Inclusion Criteria:
- History of newly diagnosed histologically confirmed squamous cell carcinoma (AJCC Stage II, III, IVA or IVB) involving either the oral cavity, oropharynx, nasopharynx, hyoppharynx, 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
- ECOG performance status less than or equal to 2
- Functional hematopoietic and hepato-renal systems
Exclusion Criteria:
- 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 pancreatitis
- Prior radiation to the site of the disease, or prior chemotherapy
Location and Contact Information
Canada, Quebec
Research Center, Montreal, Quebec, Canada; Recruiting
Research Center, Sherbrooke, Quebec, Canada; Recruiting
Willard Dere, M.D., Study Chair, Amgen
More Information
AmgenTrials clinical trials website
Center Watch Clinical Trials Listing Service
Last Updated: August 18, 2005
Record first received: July 26, 2005
ClinicalTrials.gov Identifier: NCT00131638
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-08-23
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