Combination Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

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 help reduce the side effects of these drugs.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Brigham and Women's Hospital; Massachusetts General Hospital; Sanofi
• Treatments: Ciprofloxacin; Docetaxel; Fluorouracil; Leucovorin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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