Status:
COMPLETED
Combination Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Massachusetts General Hospital
Conditions:
Squamous Cell Carcinoma
Carcinoma of Head/Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to further test a combination chemotherapy regimen for the treatment of squamous cell carcinoma of the head and neck and to see if the addition of supportive medicine can ...
Detailed Description
* Patients will be admitted to hospital and receive a one hour infusion of taxotere. Approximately 2 hours after taxotere is finished they will receive cisplatin, 5-fluorouracil, and leucovorin contin...
Eligibility Criteria
Inclusion
- Histologic confirmation of squamous cell carcinoma of head and neck.
- All patients with previously untreated Stage III or IV.
- Measurable disease
- Complete recovery from previous diagnostic or therapeutic procedures.
- Life expectancy greater than 3 months
- Creatinine less than or equal to 1.5
- SGOT less than 1.5 x ULN
- Alkaline phosphatase less than 2.5 x ULN
- WBC greater than or equal to 4,000/mm
- Platelet count greater than to equal to 100,000/mm
- Hemoglobin greater than or equal to 10gm/dl
- Patients of childbearing age must use effective contraception methods.
Exclusion
- Patients with previous head and neck cancer except those treated with surgery only.
- Patients with concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- Peripheral neuropathy exceeding grade 1.
- Cardiovascular or pulmonary disease
- Pregnant or breastfeeding women
Key Trial Info
Start Date :
January 1 1997
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00139230
Start Date
January 1 1997
End Date
December 1 2006
Last Update
June 3 2008
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115