We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Study of Taxotere, Cisplatin, 5-Fluorouracil, and Leucovorin for 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.
ClinicalTrials.gov Identifier: NCT00139243
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : June 4, 2008
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Information provided by:
Dana-Farber Cancer Institute

Brief Summary:
The purpose of this study is to determine the safety and maximum tolerated dose of the combination taxotere, cisplatin, 5-fluorouracil and leucovorin. We will also preliminarily assess whether the combination is effective in treating squamous cell carcinoma of the head and neck.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma Carcinoma of Head and/or Neck Drug: Taxotere Drug: Cisplatin Drug: 5-Fluorouracil Drug: Leucovorin Phase 1 Phase 2

Detailed Description:
  • Patients will be premedicated at home with dexamethasone and leucovorin.
  • On the first day of treatment, the patient will receive taxotere intravenously for one hour. Approximately one hour after the taxotere is completed, the patient will receive a 4 hour infusion of cisplatin and begin a four day continuous infusion of 5-fluorouracil and leucovorin. The infusion of 5-fluorouracil and leucovorin will be completed at home with the use of an infusion pump. This process will be repeated every 21-35 days (1 cycle) depending upon how quickly the patient recovers from the chemotherapy.
  • During each cycle blood tests will be performed weekly. During the first cycle a physical exam will be performed weekly and then halfway through each subsequent cycle and immediately prior to the start of each subsequent cycle.
  • At the end of each cycle the impact of the chemotherapy will be assessed. If after 2 cycles the cancer has not responded the treatment will end. If significant reduction in the size of the tumor is observed, a third and final cycle will be done.
  • After the last cycle of chemotherapy is done, radiation therapy will be performed twice daily for 6-7 weeks.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Taxotere, Cisplatin, 5-Fluorouracil and Leucovorin for Squamous Cell Carcinoma of the Head and Neck
Study Start Date : October 1997
Primary Completion Date : January 2006
Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. To determine the maximum tolerated dose of taxotere, cisplatin, 5-fluorouracil and leucovorin.

Secondary Outcome Measures :
  1. To evaluate the side effects of a four day outpatient regimen with taxotere, cisplatin, 5-fluorouracil and leucovorin
  2. to obtain preliminary information about the effectiveness of the drug combination.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Histologic documentation of squamous cell carcinoma of head and neck
  • Patients will previously untreated stage III or IV squamous cell carcinoma.
  • Patients with locally recurrent disease after surgery.
  • Life expectancy of longer than 3 months.
  • Kidney function: 1.5 or a 24 hour creatinine clearance of > 30ml/min
  • Liver function: SGOT < 1.5 X upper normal limit and alkaline phosphatase of < 2.5 X upper normal limit.
  • WBC greater than or equal to 4,000/mm
  • Platelet count greater than or equal to 100,000/mm
  • Hemoglobin greater than or equal to 10gm/dl
  • Patients of child-bearing age must use effective methods of contraception.

Exclusion Criteria:

  • Patients treated with previous chemotherapy or radiotherapy for head and neck cancer.
  • Patients with concurrent malignancy of any site except limited basal cell carcinoma, squamous carcinoma of the skin or carcinoma in situ of the cervix.
  • Pregnant or breast-feeding 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 ClinicalTrials.gov identifier (NCT number): NCT00139243

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

ClinicalTrials.gov Identifier: NCT00139243     History of Changes
Other Study ID Numbers: 97-130
First Posted: August 31, 2005    Key Record Dates
Last Update Posted: June 4, 2008
Last Verified: June 2008

Keywords provided by Dana-Farber Cancer Institute:
squamous cell carcinoma
carcinoma of head/neck

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators