Clinical trial NCT00216138 (phase 2, status: terminated)
Conditions: head and neck cancer
ICD codes: C76.0, C47.0, C49.0, C77.0, D17.0, D21.0, D36.11
Drugs: docetaxel, capecitabine, premedication
SMILES: [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
Reason stopped: 
    interim analysis results did not meet criteria for second stage of trial
  
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed recurrent or metastatic squamous cell carcinoma of the head
             and neck.

          -  Recurrent/metastatic disease not amenable to surgery or salvage chemoradiation.

          -  Unidimensional measurable disease according to the RECIST

          -  In-field recurrence, within a prior radiation field only, distant metastatic disease

          -  Both in-field and metastatic sites of disease will require evaluation by a Radiation
             Oncologist to consider local radiation therapy first and will be eligible for possible
             enrollment one month after completion of the radiation therapy.

          -  Negative pregnancy test

          -  Patients may have received prior chemotherapy as part of chemoradiation or induction
             chemotherapy for initial treatment of disease confined to the head and neck region -
             Patients must have fully recovered from any prior radiation therapy

        Exclusion Criteria:

          -  Patients who have relapsed < 6 months after completing a combined modality curative
             treatment that included a fluoropyrimidine or taxanes

          -  No brain metastases

          -  No major neurological disease, including stroke

          -  No prior chemotherapy regimen for recurrent/metastatic disease

          -  No prior history of capecitabine usage

          -  No prior history of docetaxel usage except in the induction setting for head and neck
             cancer which has been completed for greater than 6 months prior to beginning protocol
             therapy

          -  No past hypersensitivity to taxanes or 5 FU

          -  No hypersensitivity to docetaxel or other drugs formulated with polysorbate 80

          -  No current use of warfarin

          -  Patients must not be receiving ketoconazole, midazolam, erythromycin, orphenadrine,
             troleandomycin, cyclosporine or antiepileptics

          -  Patients must not be treated with any of the following on protocol therapy or within
             28 days prior to beginning protocol therapy: sorivudine, brivudine, cimetidine,
             allopurinol

          -  Patients must have fully recovered from any prior surgery

          -  No known HIV seropositivity.

          -  No serious uncontrolled medical condition, uncontrolled peptic ulcer disease or
             malabsorption syndrome

          -  No peripheral neuropathy > grade 1

          -  Patients with a percutaneous gastrostomy (PEG) must be able take medications by tube.

          -  No daily consumption of alcohol

          -  No active infection

          -  No prior history of malignancy in the last 5 years, excluding in situ carcinoma of the
             cervix or adequately treated basal or squamous cell carcinoma of the skin or Gleason
             Grade < VII organ confined prostate cancer.

          -  No current breastfeeding