GoldBamboo.com - Knowledge is strong medicine
  

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 - Article


  Not Signed In - Sign In / Register




General Topics A-Z

Factor VIIa, Recombinant

NovoSeven


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

Sponsored by: Amgen
Information provided by: Amgen
ClinicalTrials.gov Identifier: NCT00131638

Purpose

The purpose of this study is to evaluate the efficacy and safety of palifermin in reducing the incidence of severe oral mucositis in subjects with locally advanced Head and Neck Cancer receiving Radiotherapy with concurrent Chemotherapy as adjuvant treatment for their disease
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)

Further Study Details: 

Study start: January 2005
Last follow-up: December 2006

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00131638

Amgen Call Center      866-572-6436 

Canada, Quebec
      Research Center, Montreal,  Quebec,  Canada; Recruiting

      Research Center, Sherbrooke,  Quebec,  Canada; Recruiting

Study chairs or principal investigators

Willard Dere, M.D.,  Study Chair,  Amgen   

More Information

AmgenTrials clinical trials website

Center Watch Clinical Trials Listing Service

Study ID Numbers:  20040118
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


Source: ClinicalTrials.gov
Cache Date: August 24, 2005

Resources



Take control over your directory listings...INSTANTLY

Every day, thousands of users find businesses like yours in the GoldBamboo directory.

Limited Time Offer!!!

For only $50 a year, a savings of 50% off our standard rate:

  • Edit your listing (whenever you want!)
  • Link to your website
  • Choose which categories you are listed in
  • Describe your services

The process will take only a few minutes and consists of 3 easy steps:

1. Register     >     2. Edit Listings     >     3. Publish

Your Company
your street
yourtown, YS 12345
888-888-8888



No Thanks

Popular Treatments

Acne Treatment ADHD Treatment Allergy Treatment Alzheimer's Treatment
Anemia Treatment Arthritis Treatment Asthma Treatment Bipolar Disorder Treatment
Bird Flu Treatment Bladder Cancer Treatment Bladder Control Treatment Blood Pressure Treatment
Brain Tumor Treatment Breast Cancer Treatment Bronchitis Treatment Cancer Treatment
Cancer Alternative Treatment Cataract Treatment Cirrhosis Treatment Colitis Treatment
Colon Cancer Treatment Common Cold Treatment Conjunctivitis Treatment Constipation Treatment
Crohn's Disease Treatment Cystic Fibrosis Treatment Depression Treatment Dermatitis Treatment
Diabetes Treatment Edema Treatment Epilepsy Treatment Erectile Dysfunction Treatment
Fibromyalgia Treatment GERD Treatment Glaucoma Treatment Gout Treatment
Hay Fever Treatment Headache Treatment Heart Disease Treatment Hepatitis Treatment
High Blood Pressure Treatment High Cholesterol Treatment Hives Treatment Hypertension Treatment
Hypoglycemia Treatment IBS Treatment Impotence Treatment Indigestion Treatment
Infertility Treatment Influenza Treatment Insomnia Treatment Lactose Intolerance Treatment
Leukemia Treatment Lung Cancer Treatment Lyme Disease Treatment Macular Degeneration Treatment
Menopause Treatment Migraine Treatment Osteoarthritis Treatment Osteoporosis Treatment
Pancreatic Cancer Treatment PMS Treatment Pneumonia Treatment Prostate Diseases Treatment
Restless Leg Treatment Rheumatoid Arthritis Treatment Sepsis Treatment Sinusitis Treatment
Skin Cancer Treatment Sleep Apnea Treatment Snoring Treatment Stroke Treatment
Testicular Cancer Treatment
GoldBambooTM

Your Integrative Health and Wellness Resource for Factor VIIa, Recombinant.

November 18, 2008


Page Updated: June 1, 2005
============== Advertisement ==============
Disclaimer: All material displayed on the GoldBamboo.com website is provided for educational purposes only. Consult a physician regarding the applicability of any information found on GoldBamboo.com to your symptoms or medical condition.

Home | About Us | Link To Us | Feedback | Disclaimer | Privacy Policy | Terms of Use | Google Co-op | Health Forums

Copyright © 2004-2008 - Gold Bamboo LLC
All rights reserved.

HONcode accreditation seal.

We comply with the HONcode standard for health trust worthy information:
verify here.