Clinical trial NCT00113399 (phase 3, status: terminated)
Conditions: head and neck cancer
ICD codes: C76.0, C47.0, C49.0, C77.0, D17.0, D21.0, D36.11
Drugs: cisplatin, docetaxel, fluorouracil, paclitaxel
SMILES: [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC
Reason stopped: 
    terminated early due to low accrual.
  
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)