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

Phase 2
18 Years
Not Enrolling
Squamous Cell Carcinoma, Carcinoma of Head/Neck

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Trial Information

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

- 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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety of a four day regimen of taxotere, cisplatin, 5-fluorouracil and high-dose leucovorin with growth factor support and ciprofloxacin.

Principal Investigator

Marshall Posner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

January 1997

Completion Date:

December 2006

Related Keywords:

  • Squamous Cell Carcinoma
  • Carcinoma of Head/Neck
  • Squamous Cell Carcinoma of Head and Neck
  • Compressed TPFL
  • Taxotere
  • Growth Factor Support
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617