Cisplatin and Docetaxel Plus Docetaxel and Radiotherapy With Amifostine for Squamous Cell Carcinoma of the Head and Neck
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|ClinicalTrials.gov Identifier: NCT00318890|
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : February 14, 2011
|Condition or disease||Intervention/treatment||Phase|
|Cancer of Head and Neck Head Cancer Head and Neck Cancer Neck Cancer Neck Neoplasms||Drug: Cisplatin Drug: Docetaxel Procedure: Radiotherapy Drug: Amifostine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Trial of Induction Cisplatin and Docetaxel Followed by Concomitant Docetaxel/Radiotherapy With Subcutaneous Amifostine for Locally Advanced Squamous Cell Carcinoma of the Head and Neck|
|Study Start Date :||October 2002|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||December 2007|
Experimental: Docetaxel + cisplatin followed by radiation
Docetaxel with cisplatin is given for three cycles, followed by concomitant therapy with weekly docetaxel for 4 weeks. Radiation therapy is given 5 days each week on Days 64-106 with a concomitant boost in the last 2 weeks of treatment. Amifostine is given as an injection on a daily basis during radiotherapy.
Cisplatin is given at a dose of 75 mg/m2 intravenously for three cycles on Days 1, 21, and 43.
Other Name: Platinol-AQ
Docetaxel is given at a dose of 75 mg/m2 intravenously on Days 1, 21, and 43 and continued at variable doses for 4 weeks with standard radiotherapy.
Other Name: Taxotere
Radiation therapy will be given 5 days each week for 4 weeks plus a concomitant boost in the last 2 weeks of treatment to deliver 54 Gy in 30 fractions. Radiotherapy will follow the induction chemotherapy with docetaxel and cisplatin.
Amifostine will be administered as a subcutaneous injection on a daily basis during radiotherapy.
Other Name: Ethyol
- To establish the response rate to chemotherapy followed by docetaxel with radiotherapy and to assess overall survival, local-regional recurrence rate and effects on the quality of life. [ Time Frame: approximately 4 months ]
- To evaluate the toxicities of chemotherapy followed by concomitant docetaxel with radiotherapy in patients. [ Time Frame: approximately 4 months ]
- To evaluate tumor specimens for intermediary biomarkers of response or prognosis as compared to normal tissue [ Time Frame: approximately 4 months ]
- To assess the tolerance to subcutaneous amifostine and its effect on saliva production. [ Time Frame: approximately 4 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00318890
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||Lisle Nabell, M.D.||University of Alabama at Birmingham|