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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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

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

Secondary Outcome Measures:
  • 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.

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

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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139243

Locations
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
Sanofi
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Marshall Posner, MD Dana-Farber Cancer Institute
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00139243     History of Changes
Other Study ID Numbers: 97-130
Study First Received: August 29, 2005
Last Updated: June 2, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
squamous cell carcinoma
Taxotere
carcinoma of head/neck
Cisplatin
5-Fluorouracil
Leucovorin

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Docetaxel
Cisplatin
Fluorouracil
Leucovorin
Levoleucovorin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on July 26, 2014