Clinical trial NCT00006107: Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Official title: Taxotere Plus Concurrent Concomitant Boost Radiotherapy For Squamous Cell Cancer of the Head and Neck (TAXT-XRT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Head and Neck Cancer
Keywords: recurrent metastatic squamous neck cancer with occult primary
metastatic squamous neck cancer with occult primary squamous cell carcinoma
stage III squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx
recurrent squamous cell carcinoma of the nasopharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
recurrent 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
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent salivary gland cancer
stage III salivary gland cancer
stage IV salivary gland cancer
salivary gland squamous cell carcinoma
recurrent lymphoepithelioma of the nasopharynx
recurrent lymphoepithelioma of the oropharynx
stage III lymphoepithelioma of the nasopharynx
stage III lymphoepithelioma of the oropharynx
stage IV lymphoepithelioma of the nasopharynx
stage IV lymphoepithelioma of the oropharynx
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase I trial to study the effectiveness of docetaxel plus radiation therapy in treating patients who have stage III or stage IV head and neck cancer.

Detailed description: OBJECTIVES:

* Determine the maximum tolerated dose of docetaxel when administered with concurrent boost radiotherapy in patients with advanced squamous cell carcinoma of the head and neck previously treated with induction chemotherapy.
* Determine the toxicity of this treatment regimen in this patient population.
* Determine the efficacy of this treatment regimen in these patients.

OUTLINE: This is a dose escalation study of docetaxel.

Patients receive docetaxel IV over 1 hour weekly for 4 weeks. Patients also undergo hyperfractionated radiotherapy daily, 5 days a week, for 4 weeks followed by radiotherapy alone twice daily for 2 weeks.

Upon completion of chemoradiotherapy, patients not achieving complete response to induction chemotherapy undergo neck surgical dissection at 4-12 weeks following completion of radiotherapy.

Cohorts of 3-5 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is reached. The MTD is the dose preceding that at which 2 of 3 or 2 of 5 patients experience dose limiting toxicity. Additional patients are treated at the MTD.

Patients are followed monthly for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 18-25 patients will be accrued for this study.

Eligibility criteria: Inclusion Criteria:

* Pathology:

  -- Histologic documentation of squamous cell carcinoma of the head and neck or its variants (lymphoepithelioma, undifferentiated epidermoid carcinoma, etc.).
* Stage:

  -- Patients will be entered on this protocol after initial induction therapy, if, prior to the induction regimen, they were previously untreated Stage III or IV (MO) SCCHN. Evaluable disease during induction therapy is required.
  * Required Prior Therapy: Patients entered on this protocol will have received platinum/FUra based induction chemotherapy. They may have received a taxane as part of this plan.
  * Patients treated with induction are eligible provided that they receive no more than 3 cycles of chemotherapy, but at least one cycle of chemotherapy, and are less then 7 weeks from the start of last cycle of induction therapy.
* Other Malignancies:

  * Patients with previous head and neck cancer are ineligible, except patients who were treated with surgery as the sole modality ≥2 years prior to study entry.
  * 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 are ineligible.
  * Patients with any non-SCCHN malignancy within 3 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix are ineligible.
* Other Prior Therapy:

  * Patients treated with induction therapy
  * Hormonally treated patients are eligible.
* Performance: Patients must meet the following performance criteria:

  * Performance status: ≤2 (ECOG) Complete recovery from previous diagnostic or therapeutic procedures is required.
  * Nutritional Status: Adequate and nutritionally balanced enteral intake ≥ 1,800 kcal/day).
  * A PEG is required prior to initiation of radiation.
  * Age: ≥18 years
  * Life Expectancy: Longer than 3 months.
  * Women of child bearing potential must not be pregnant by history or lactating at the time of entry on this protocol and men and women of child bearing potential must be requested to use an accepted and effective method of birth control during therapy.
* Organ Function: Biochemical and hematological parameters (obtained within 2 weeks of study entry) as follows:

  * Hepatic: SGOT \< 1.5 x ULN and Alkaline Phosphatase \< 2.5 x ULN for entry. Total Bilirubin = WNL and SGOT must be ≤ 2 x ULN as an isolated value. SGPT ≤ 2.5 x ULN
  * Hematologic: WBC ≥ 3,000/mm3 or a normal absolute neutrophil count (ANC) ≥ 1000; Platelet count ≥ 100,000/mm3 Hemoglobin ≥ 10 gm/d1 (transfusion to bring the hemoglobin to or above this level is permitted if clinically indicated, however, transfusions should not be used solely in order to meet eligibility criteria).
* Neurologic: Peripheral neuropathy of any etiology must not exceed grade 2.
* Other: Lack of other serious illness or medical condition
* Informed consent:

  -- Patients must give written informed consent.
* Follow-up:

  * All patients must be available for monthly evaluation and re-staging by the physicians from the Head and Neck Cancer Clinic while on therapy.

Exclusion Criteria:

* Pathology:

  -- Patients with previous head and neck cancer are ineligible, except patients who were treated with surgery as the sole modality ≥ 2 years prior to study entry.
* Other Malignancies:

  * 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 are ineligible.
  * Patients with any non-SCCHN malignancy within 3 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix are ineligible.
* Other Prior Therapy:

  * Patients who were previously treated with radiotherapy for SCCHN are not eligible.
  * Patients treated with any form of prior chemotherapy, other than induction therapy within the last 5 years are not eligible
* Performance:

  * Nutritional Status: Patients requiring intravenous alimentation as primary source of calories are excluded from this study.
  * Patients with persistent diarrhea are ineligible.
* Organ Function:

  -- Neurologic: Peripheral neuropathy of any etiology must not exceed grade 2.

  -- Cardiovascular/Pulmonary: No acute cardiac dysrhythmias or unstable cardiac condition such as angina.
* Follow-up:

  * Patients with a history of severe hypersensitivity reaction to Taxotere or other drugs formulated with polysorbate 80 will be excluded.

Primary outcomes:
measure: MTD of Taxotere
timeFrame: 8 Weeks
measure: Dose Limiting Toxicity
timeFrame: 8 Weeks
Secondary outcomes:
measure: Overall Response Rate
timeFrame: 4-12 weeks post chemo/radiation therapy
measure: Tumor Resistance Predictors
timeFrame: Up to 1 year post chemo/radiation therapy
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Roy B. Tishler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: