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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00139230
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : June 3, 2008
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by:
Dana-Farber Cancer Institute

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 Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
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 : January 1997
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. To determine the efficacy of this regimen in patients with advances, previously untreated squamous cell carcinoma of the head and neck.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00139230

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Principal Investigator: Marshall Posner, MD Dana-Farber Cancer Institute

Publications: Identifier: NCT00139230     History of Changes
Other Study ID Numbers: 96-184
First Posted: August 31, 2005    Key Record Dates
Last Update Posted: June 3, 2008
Last Verified: June 2008

Keywords provided by Dana-Farber Cancer Institute:
Squamous Cell Carcinoma of Head and Neck
Compressed TPFL
Growth Factor Support

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors