Study of Taxotere, Cisplatin, 5-Fluorouracil, and Leucovorin for Squamous Cell Carcinoma of the Head and Neck

This study has been completed.
Sponsor:
Collaborators:
Sanofi
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00139243
First received: August 29, 2005
Last updated: June 2, 2008
Last verified: June 2008

August 29, 2005
June 2, 2008
October 1997
January 2006   (final data collection date for primary outcome measure)
To determine the maximum tolerated dose of taxotere, cisplatin, 5-fluorouracil and leucovorin.
Same as current
Complete list of historical versions of study NCT00139243 on ClinicalTrials.gov Archive Site
  • To evaluate the side effects of a four day outpatient regimen with taxotere, cisplatin, 5-fluorouracil and leucovorin
  • to obtain preliminary information about the effectiveness of the drug combination.
Same as current
Not Provided
Not Provided
 
Study of Taxotere, Cisplatin, 5-Fluorouracil, and Leucovorin for Squamous Cell Carcinoma of the Head and Neck
A Phase I/II Study of Taxotere, Cisplatin, 5-Fluorouracil and Leucovorin for Squamous Cell Carcinoma of the Head and Neck

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.

  • 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.
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Squamous Cell Carcinoma
  • Carcinoma of Head and/or Neck
  • Drug: Taxotere
  • Drug: Cisplatin
  • Drug: 5-Fluorouracil
  • Drug: Leucovorin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
January 2006
January 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00139243
97-130
Not Provided
Not Provided
Dana-Farber Cancer Institute
  • Sanofi
  • Brigham and Women's Hospital
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
Principal Investigator: Marshall Posner, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP