Combination Chemotherapy and Radiation in Treating Patients With Stage III or IV Head and Neck Cancer (Paradigm Trial)
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: carboplatin; cisplatin; docetaxel; fluorouracil
Intervention description: Given IV; Given IV; Given IV; Given IV
Intervention MeSH terms: Carboplatin; Docetaxel; Fluorouracil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 145.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage III squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the oropharynx

Summary:

      RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, fluorouracil, and
      carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or
      die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy
      with radiation therapy may kill more tumor cells. It is not yet known which regimen of
      chemotherapy and radiation therapy is most effective in treating head and neck cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of
      chemotherapy and radiation therapy in treating patients who have stage III or stage IV head
      and neck cancer.
    

Eligibility criteria:

        List of Inclusion Criteria:

          -  Histologically or cytologically confirmed squamous cell carcinoma of the head and neck

               -  Stage III or IV* disease

               -  One of the following primary tumor sites:

                    -  Oral cavity

                         -  No mandible invasion

                    -  Oropharynx

                    -  Hypopharynx

                    -  Larynx

               -  The following primary tumor sites are excluded:

                    -  Nasal cavity

                    -  Paranasal cavity

                    -  Nasopharynx NOTE: *No evidence of distant metastases by chest x-ray,
                       abdominal ultrasound, or CT scan (for patients with liver function test
                       abnormalities) or bone scan (for patients with local symptoms)

          -  At least 1 uni- or bi-dimensionally measurable lesion

        PATIENT CHARACTERISTICS:

        Age

          -  Over 18

        Performance status

          -  WHO 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Neutrophil count > 1,500/mm^3

          -  Platelet count > 100,000/mm^3

          -  Hemoglobin > 10 g/dL

        Hepatic

          -  Bilirubin normal

          -  AST or ALT within eligibility range

          -  Alkaline phosphatase within eligibility range

        Renal

          -  Creatinine clearance > 60 mL/min

        Cardiovascular

          -  No unstable cardiac disease despite treatment

          -  No myocardial infarction within the past 6 months

        Pulmonary

          -  No chronic obstructive pulmonary disease, defined as requiring hospitalization for
             pneumonia or respiratory decompensation within the past year

               -  Obstruction caused by the tumor allowed

        Neurologic

          -  No symptomatic peripheral neuropathy > grade 2

          -  No symptomatic altered hearing > grade 2

          -  No history of significant neurologic or psychiatric disorders, including dementia or
             seizures

        Other

          -  No active drug addiction, including alcohol, cocaine, or intravenous drugs within the
             past 6 months

          -  No other malignancy within the past 5 years except adequately treated carcinoma in
             situ of the cervix, basal cell or squamous cell skin cancer, or other cancer
             curatively treated by surgery alone

          -  No active, clinically significant, uncontrolled infection

          -  No autoimmune disease requiring therapy

          -  No unhealed or clinically active peptic ulcer disease

          -  No hypercalcemia

          -  No other serious illness or medical condition

          -  No involuntary weight loss > 25% of body weight within the past 2 months

          -  HIV negative

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for at least 3 months
             after study participation

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  No prior chemotherapy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No prior radiotherapy

        Surgery

          -  No prior organ transplantation

          -  No prior surgery for this cancer

               -  Biopsy allowed

        Other

          -  More than 30 days since prior participation in another investigational study

          -  No other concurrent anticancer therapy