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

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Sanofi
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00139230
First received: August 29, 2005
Last updated: June 2, 2008
Last verified: June 2008
  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 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: TPLF-4, Compressed TPLF for Locally Advanced Squamous Cell Carcinoma

Resource links provided by NLM:


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
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: 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
Investigators
Principal Investigator: Marshall Posner, MD Dana-Farber Cancer Institute
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00139230     History of Changes
Other Study ID Numbers: 96-184
Study First Received: August 29, 2005
Last Updated: June 2, 2008
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:
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Fluorouracil
Ciprofloxacin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 01, 2014