Official Title: “TPLF-4, Compressed TPLF for Locally Advanced Squamous Cell Carcinoma”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2006

- 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 continuously over a 4 day period. - Approximately 6-12 hours after the chemotherapy ends patients will be given growth factor support and ciprofloxacin until the patient's ANC level is greater than 10,000. - Infusion of chemotherapy will be repeated every 28 days (1 cycle is 28 days). - During each cycle patients will have blood tests performed weekly and may be asked to return to the Head and Neck Clinic for examination around the middle of each cycle. - At the end of each cycle the impact of the chemotherapy will be assessed. If after 2 cycles, the cancer has not responded sufficiently the patient will not receive any more chemotherapy. However, if significant reduction in the size of the patients tumor is observed, a third and final cycle will be performed. - During the fourth or fifth week of cycle 3, patients will undergo re-staging evaluation under anesthesia with primary-site biopsies and planning of radiotherapy. - Within 2 weeks of completion of chemotherapy cycle 3 all patients will receive twice daily radiotherapy.

Intervention(s) in this Clinical Trial

• Drug: Taxotere
• Drug: Cisplatin
• Drug: 5-Fluorouracil
• Drug: Leucovorin
• Drug: G-CSF
• Drug: Ciprofloxacin

Primary Measures

• To evaluate the safety of a four day regimen of taxotere, cisplatin, 5-fluorouracil and high-dose leucovorin with growth factor support and ciprofloxacin.

Secondary Measures

• To determine the efficacy of this regimen in patients with advances, previously untreated squamous cell carcinoma of the head and neck.

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Dana-Farber Cancer Institute

Overall Clinical Trial Officials and Contacts

Marshall Posner, MD Principal Investigator Dana-Farber Cancer Institute  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00139230

Study ID Number: 96-184

ClinicalTrials.gov Identifier: NCT00139230

Health Authority: United States: Institutional Review Board