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Head and Neck Cancer

Erlotinib + Cisplatin/Radiotherapy (6106)
A Multicenter Randomized Phase II Study of Erlotinib (Tarceva), Cisplatin and Radiotherapy Versus Cisplatin and Radiotherapy in Patients With Stage III and IV Squamous Cell Carcinoma of the Head and Neck
Status Conditions Phase Study ID
Closed Head and Neck Cancer Phase II 6106
NCT00410826
Summary

The purpose of this study is to determine the safety and effectiveness of treating patients who have advanced head and neck cancer with the drug erlotinib, given in addition to the drug cisplatin and radiotherapy. This research is being done to compare the effects, good and/or bad, of treatment with erlotinib, cisplatin and radiotherapy, versus the current, standard treatment, which uses cisplatin and radiotherapy alone. This study will compare two groups of participants: One group will receive the standard treatment of cisplatin and radiotherapy alone; the other group will receive the drug erlotinib in addition to the standard treatment. Assignment to either group of participants is random (by chance).


Investigator
Renato G. Martins, MD, MPH
Location    
Seattle Cancer Care Alliance 800-804-8824  
Multicare Health System, Tacoma WA 253-403-5265  
Eligibility Criteria (must meet the following to participate in this study)

Eligibility Criteria (must meet the following to participate in this study)
1. Patient has stage III or stage IV squamous cell carcinoma of the head and neck that is inoperable.
2. Patient is 18 years of age or older.
3. Male and female patients with reproductive potential must be willing to use an acceptable contraceptive method.
4. Patient has authorization from a dentist to begin radiation therapy.
Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)
1. Other cancer in past 5 years (except non-melanoma skin cancer)
2. Congestive heart failure
3. Chronic diarrhea
4. Prior radiation, chemotherapy, or investigational treatment for head and neck cancer
5. Pregnant or breastfeeding women

Last Updated
June 06, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.