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

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00139230

Collaborator

Brigham and Women's Hospital (Other), Massachusetts General Hospital (Other), Sanofi (Industry)

Enrollment

Locations

119

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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 help reduce the side effects of these drugs.

Condition or Disease	Intervention/Treatment	Phase
Squamous Cell Carcinoma Carcinoma of Head/Neck	Drug: Taxotere Drug: Cisplatin Drug: 5-Fluorouracil Drug: Leucovorin Drug: G-CSF Drug: Ciprofloxacin	Phase 2

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 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.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

TPLF-4, Compressed TPLF for Locally Advanced Squamous Cell Carcinoma

Study Start Date :

Jan 1, 1997

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Dec 1, 2006

Outcome Measures

Primary Outcome 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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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