Clinical trial NCT00025298 (phase 2, status: terminated)
Conditions: drug/agent toxicity by tissue/organ, head and neck cancer, oral complications, radiation toxicity
ICD codes: T86.91, T86.92, T86.93, Z52.9, Z94.89, Z94.9, T86.90, C76.0, C47.0, C49.0, C77.0, D17.0, D21.0, D36.11, E10.638, E11.638, E13.638, E08.638, E09.638, K62.7, G62.82, N46.024, N46.124, T66.XXXS, Z57.1, N52.35
Drugs: amifostine trihydrate, carboplatin, cisplatin, paclitaxel
SMILES: NCCCNCCSP(O)(O)=O, N[C@@H](CCCNC(N)=N)C(O)=O, [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][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: 
    low accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed undifferentiated nasopharyngeal cancer (UNPC)

               -  Locoregionally advanced disease

                    -  T2b, N1 (greater than 3 cm) or N2

                    -  T3, N1 (greater than 3 cm) or N2

                    -  T4, N1 (greater than 3 cm) or N2

                    -  Any T, N3

               -  No squamous cell histology

          -  At least 1 unidimensionally measurable target lesion

               -  At least 20 mm by conventional techniques OR

               -  At least 10 mm by spiral CT scan

          -  No evidence of distant metastases

          -  No signs or symptoms of CNS metastases

        PATIENT CHARACTERISTICS:

        Age:

          -  15 to 70

        Performance status:

          -  WHO 0-2

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  Absolute neutrophil count at least 2,000/mm^3

          -  Platelet count at least 150,000/mm^3

          -  Hemoglobin at least 12 g/dL

        Hepatic:

          -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)

          -  AST/ALT no greater than 2.5 times ULN

        Renal:

          -  Creatinine clearance at least 70 mL/min

          -  Calcium normal

        Cardiovascular:

          -  No hypotension or hypertension requiring therapy

          -  No prior myocardial infraction

          -  No pre-existing uncontrolled cardiac disease

          -  No signs of cardiac failure

          -  No rhythm disturbances requiring medication

        Other:

          -  No sensory neuropathy grade 2 or greater unless due to cranial nerve

          -  No uncontrolled infections

          -  No sensitivity to aminothiol compounds

          -  No other malignancy within the past 5 years except adequately controlled carcinoma in
             situ of the cervix or basal cell or squamous cell skin cancer

          -  No psychological, familial, sociological, or geographical condition that would
             preclude study

          -  Fertile patients must use effective contraception during and for 3 months after study

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  No concurrent immunotherapy

        Chemotherapy:

          -  No prior chemotherapy for UNPC

        Endocrine therapy:

          -  No concurrent hormonal therapy except corticosteroids for antiemetic prophylaxis

        Radiotherapy:

          -  No prior radiotherapy for UNPC

        Surgery:

          -  No prior surgery for UNPC except cervical lymphadenectomy

        Other:

          -  At least 1 month since prior investigational agent

          -  No other concurrent anticancer drugs