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Completed

NCT Number: NCT00139230

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

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.

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Key information

Conditions

Squamous Cell Carcinoma Carcinoma Carcinoma of Head/Neck Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Taxotere

Drug

Cisplatin

Drug

5-fluorouracil

Drug

Leucovorin

Drug

G-CSF

Drug

Ciprofloxacin

Drug

Primary outcomes

  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 outcomes

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

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Brigham and Women's Hospital
  • Massachusetts General Hospital
  • Sanofi

Registry information

Official study title

TPLF-4, Compressed TPLF for Locally Advanced Squamous Cell Carcinoma

Important dates

Study start
1997
Primary completion
2006
Study completion
2006
First posted
Aug 31, 2005
Registry last updated
Jun 3, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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