Combination Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck - Full Text View

Sponsor:	Dana-Farber Cancer Institute
Collaborators:	Brigham and Women's Hospital Massachusetts General Hospital Sanofi-Aventis
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00139230

Purpose

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	Intervention	Phase
Squamous Cell Carcinoma Carcinoma of Head/Neck	Drug: Taxotere Drug: Cisplatin Drug: 5-Fluorouracil Drug: Leucovorin Drug: G-CSF Drug: Ciprofloxacin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	TPLF-4, Compressed TPLF for Locally Advanced Squamous Cell Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Fluorouracil Leucovorin Cisplatin Citrovorum factor Ciprofloxacin Ciprofloxacin hydrochloride Ciprofloxacin lactate Docetaxel Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

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.

Estimated Enrollment:	30
Study Start Date:	January 1997
Study Completion Date:	December 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139230

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Massachusetts General Hospital

Sanofi-Aventis

Investigators

Principal Investigator:

Marshall Posner, MD

Dana-Farber Cancer Institute

More Information

Publications:

Haddad R, Colevas AD, Tishler R, Busse P, Goguen L, Sullivan C, Norris CM, Lake-Willcutt B, Case MA, Costello R, Posner M. Docetaxel, cisplatin, and 5-fluorouracil-based induction chemotherapy in patients with locally advanced squamous cell carcinoma of the head and neck: the Dana Farber Cancer Institute experience. Cancer. 2003 Jan 15;97(2):412-8.

Colevas AD, Norris CM, Tishler RB, Lamb CC, Fried MP, Goguen LA, Gopal HV, Costello R, Read R, Adak S, Posner MR. Phase I/II trial of outpatient docetaxel, cisplatin, 5-fluorouracil, leucovorin (opTPFL) as induction for squamous cell carcinoma of the head and neck (SCCHN). Am J Clin Oncol. 2002 Apr;25(2):153-9.

Goguen LA, Posner MR, Tishler RB, Wirth LJ, Norris CM, Annino DJ, Sullivan CA, Li Y, Haddad RI. Examining the need for neck dissection in the era of chemoradiation therapy for advanced head and neck cancer. Arch Otolaryngol Head Neck Surg. 2006 May;132(5):526-31.

Haddad R, Tishler R, Wirth L, Norris CM, Goguen L, Sullivan C, O'Donnell L, Li Y, Posner M. Rate of pathologic complete responses to docetaxel, cisplatin, and fluorouracil induction chemotherapy in patients with squamous cell carcinoma of the head and neck. Arch Otolaryngol Head Neck Surg. 2006 Jun;132(6):678-81.

Study ID Numbers:	96-184
Study First Received:	August 29, 2005
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00139230 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

Squamous Cell Carcinoma of Head and Neck
Compressed TPFL
Taxotere
Growth Factor Support

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Leucovorin
Docetaxel
Ciprofloxacin
Cisplatin
Vitamins
Therapeutic Uses
Micronutrients

Neoplasms, Squamous Cell
Nucleic Acid Synthesis Inhibitors
Neoplasms by Histologic Type
Vitamin B Complex
Growth Substances
Enzyme Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Fluorouracil
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010