Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: filgrastim; cisplatin; docetaxel; fluorouracil; paclitaxel; radiation therapy
Intervention MeSH terms: Paclitaxel; Docetaxel; Fluorouracil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the larynx; recurrent squamous cell carcinoma of the lip and oral cavity; recurrent squamous cell carcinoma of the oropharynx; recurrent metastatic squamous neck cancer with occult primary; recurrent lymphoepithelioma of the oropharynx

Summary:

      RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in
      chemotherapy work in different ways to stop the growth of tumor cells, either by killing the
      cells or by stopping them from dividing. Cisplatin and paclitaxel may make tumor cells more
      sensitive to radiation therapy. Giving more than one drug (combination chemotherapy) and
      giving them with radiation therapy may kill more tumor cells. It is not yet known whether
      giving radiation therapy together with combination chemotherapy is more effective than giving
      combination chemotherapy alone in treating head and neck cancer.

      PURPOSE: This randomized phase III trial is studying radiation therapy and combination
      chemotherapy to see how well they work compared to combination chemotherapy alone in treating
      patients with recurrent head and neck cancer that cannot be removed by surgery.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically* or cytologically* confirmed squamous cell carcinoma (SCC) of the oral
             cavity, oropharynx, hypopharynx, or larynx, including any of the following histologic
             variants:

               -  Spindle cell carcinoma

               -  Poorly differentiated keratin-positive carcinoma

               -  Lymphoepithelioma NOTE: *Biopsy or primary tumor and/or fine needle aspiration of
                  the metastatic lymph node required

          -  Original or second primary tumor

               -  Recurrent neck metastases with unknown primary allowed

          -  Locally recurrent disease

          -  Measurable disease

          -  Unresectable disease

               -  Attempted surgical resection allowed provided surgery was performed ≥ 3 months
                  ago, wound is completely healed, and there is no sign of carotid exposure

          -  Must have had prior radiotherapy for SCC of the head and neck with > 75% of the
             present tumor volume in areas irradiated at doses ≥ 45 Gy but ≤ 75 Gy

               -  Able to successfully re-irradiate the area of the gross tumor volume without
                  exceeding lifetime spinal cord dose of 54 Gy as determined by physical
                  examination and CT scan and/or MRI performed within the past 8 weeks

               -  First recurrence occurred > 6 months after completion of radiotherapy

                    -  More than 1 recurrence allowed provided the above criteria for first
                       recurrence has been met

          -  No primary tumor of the nasopharynx or salivary gland

          -  No distant metastases by history or physical examination, chest CT scan, and CT scan
             or MRI of the tumor site

               -  Patients with equivocal pulmonary nodules are eligible provided the nodules are <
                  1 cm, can be safely biopsied, or are negative by positron emission tomography
                  imaging

               -  No circumferential tumor involvement of the carotid sheath by imaging unless
                  prophylactic carotid stent is placed

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Zubrod 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count ≥ 1,800/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)

        Hepatic

          -  AST or ALT < 2 times upper limit of normal (ULN)

          -  Bilirubin < 1.5 mg/dL

          -  No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

        Renal

          -  Creatinine clearance > 50 mL/min

          -  Calcium < 11.5 mg/dL

        Cardiovascular

          -  No New York Heart Association class III or IV heart disease

          -  No other symptomatic or uncontrolled cardiac disease

        Pulmonary

          -  No chronic obstructive pulmonary disease exacerbation

          -  No other respiratory illness requiring hospitalization within the past 6 months or
             that would preclude study therapy

        Immunologic

          -  No AIDS

          -  No prior allergic reaction to E. coli-derived products

          -  No acute bacterial or fungal infection requiring IV antibiotics

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 30 days after
             completion of study treatment

          -  No other invasive malignancy within the past 3 years except nonmelanoma skin cancer,
             carcinoma in situ of the breast, oral cavity, or cervix

          -  No pre-existing peripheral sensory neuropathy > grade 2

          -  No other severe active co-morbidity

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  At least 6 months since prior chemotherapy

          -  No prior systemic chemotherapy for recurrent SCC of the head and neck

               -  Prior neoadjuvant, adjuvant, and/or concurrent chemotherapy and radiotherapy for
                  initial SCC of the head and neck allowed

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  See Disease Characteristics

          -  See Chemotherapy

          -  At least 6 months since prior radiotherapy

        Surgery

          -  See Disease Characteristics

        Other

          -  Prior cyclooxygenase-2 inhibitor or retinoids for chemoprevention allowed

          -  At least 6 months since prior epidermal growth factor receptor (EGFR) inhibitors or
             other targeted agents

          -  No prior EGFR inhibitors or other targeted agents for recurrent SCC of the head and
             neck

          -  No concurrent cimetidine or allopurinol (for patients on arm II, regimen 1)