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Taxotere Plus Concurrent Radiotherapy After Induction Chemotherapy for Squamous Cell Carcinoma of the Head and Neck (TAXT-XRT)


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

Taxotere Plus Concurrent Radiotherapy After Induction Chemotherapy for Squamous Cell Carcinoma of the Head and Neck (TAXT-XRT)


OBJECTIVES: I. Determine the maximum tolerated dose of weekly docetaxel when administered as
concurrent therapy with radiation therapy after treatment with induction chemotherapy in
patients with squamous cell carcinoma of the head and neck. II. Determine the toxicity
profile of this regimen in these patients. III. Obtain preliminary assessment of the
efficacy of this regimen in these patients. IV. Study potential predictors of tumor
resistance prospectively through tumor biopsies and tissues.

OUTLINE: This is a dose escalation study. Patients are administered 1 hour IV infusions of
docetaxel weekly for 6 weeks concurrently with radiation therapy 5 days a week for 6 weeks.
Patients are treated in cohorts of 3-5 patients per dose. An entire cohort must complete
treatment at a given dose level before a new cohort is accrued at a higher dose. The maximum
tolerated dose (MTD) is the dose level below that at which dose limiting toxicity occurs in
2 of 5 patients. At the MTD, 15 additional patients are treated to assess for toxicity.
Patients are followed every 3 months until disease progression or death.

PROJECTED ACCRUAL: A maximum of 35 patients is accrued into this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the head and
neck or its variants (lymphoepithelioma, undifferentiated epidermoid carcinoma, etc.)
Previously untreated Stage III or IV (M0) No exophytic T3 N0 tumors or T1 N1 lesions May
be entered after initial induction therapy Evaluable disease Must have received therapy
with one of the following induction regimens, except as modified for toxicity: - Cisplatin
at least 80 mg/m2/cycle and fluorouracil at least 1000 mg/m2/day for at least 4 days every
4 weeks - Carboplatin at least 300 mg/m2/cycle and fluorouracil at least 1000 mg/m2/day
for at least 4 days every 4 weeks - Cisplatin at least 25 mg/m2/day over 5 days,
fluorouracil at least 800 mg/m2/day on days 2-5 and leucovorin at least 500 mg/m2/day over
5 days, every 4 weeks

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy:
Greater than 3 months Hematopoietic: WBC at least 4,000/mm3 Absolute neutrophil count
normal Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL (transfusions
permitted, if not used solely for achieving the eligibility criteria) Hepatic: SGOT less
than 1.5 times upper limit of normal (ULN) Total bilirubin and SGOT no greater than 2
times ULN as an isolated value Alkaline phosphatase less than 2.5 times ULN Alkaline
phosphatase no greater than 2.5 times ULN as an isolated value Renal: Not specified
Cardiovascular: No acute cardiac dysrhythmias or unstable cardiac conditions such as
angina Neurology: No peripheral neuropathy greater than grade 1 Nutritional status:
Adequate and nutritionally balanced enteral intake (at least 1,800 kcal/day) No
intravenous alimentation as primary source of calories No weight loss of greater than 20%
of body weight in past 3 months Other: No prior allergy to polysorbate 80 No other serious
illness or medical condition No persistent diarrhea No other prior or concurrent
malignancy, unless disease free for at least 5 years, except: Limited basal cell carcinoma
of the skin Squamous cell carcinoma of the skin Carcinoma in situ of the cervix Not
pregnant or nursing Adequate contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy within 5 years other than described in Disease Characteristics No greater
than 3 cycles of prior chemotherapy as described in Disease Characteristics Endocrine
therapy: Prior hormone therapy allowed Radiotherapy: No prior radiotherapy for squamous
cell cancer of the head and neck Surgery: May have undergone surgery as the sole treatment
for disease 2 or more years prior to study

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Marshall R. Posner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000066044

NCT ID:

NCT00003200

Start Date:

October 1995

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the oropharynx
  • stage III lymphoepithelioma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • stage IV lymphoepithelioma of the oropharynx
  • stage III squamous cell carcinoma of the nasopharynx
  • stage III lymphoepithelioma of the nasopharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • stage IV lymphoepithelioma of the nasopharynx
  • stage III squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Brigham and Women's HospitalBoston, Massachusetts  02115
Harvard Community Health PlanBoston, Massachusetts  02215