Phase II (Treatment) Study of Oxaliplatin and Capecitabine in Advanced Head and Neck Malignancies
Condition: Head or Neck Cancer
MeSH terms: Neoplasms; Head and Neck Neoplasms
Intervention: Oxaliplatin, Capecitabine
Intervention description: Agent, DOSE AND SCHEDULE (28-days cycle):
Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21
Intervention MeSH terms: Capecitabine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II study will test the response rate of combined oxaliplatin and capecitabine
      treatment when administered at a given dose and schedule, in patients with Head and Neck
      cancer for which there is no curative treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed squamous cell cancer of
             Head and Neck

          -  Patients must have metastatic or locally recurrent disease

          -  Patients must have disease not curable by surgery as estimated by one of the protocol
             investigators, and should not be eligible for reradiation protocol or have failed
             reradiation protocol.

          -  Patients must have measurable disease, defined as at least one lesion that can be
             accurately measured in at least one dimension (longest diameter to be recorded) as >20
             mm with conventional techniques or as >10 mm with spiral CT scan

          -  Age >18 years of age

          -  Life expectancy of greater than 12 weeks

          -  ECOG performance status 0, 1 or 2 (Karnofsky >50%; see Appendix B)

          -  Patients must have adequate bone marrow function as defined below:

               -  absolute neutrophil count > 1,500

               -  platelets > 100,000

               -  hemoglobin > 8 g/dl

          -  Patients must have adequate renal function as defined by a creatinine clearance >30
             mL/min (measured or estimated by the Cockroft and Gault equation)

               -  Cockroft and Gault equation:

               -  Creatinine clearance for males =(140-age[yrs])(body wt[kg])/72(serum
                  creatinine[mg/dL])

               -  Creatinine clearance for females = 0.85 x male value

          -  Patients must have adequate liver function as defined below:

               -  total bilirubin 1.5x upper limit of normal

               -  albumin > 2.5 g/dl

               -  AST(SGOT) and ALT(SGPT) and Alkaline Phosphatase must be < 5 times upper limit of
                  normal

          -  Patients could have received 1 or 2 previous chemotherapy regimens prior to entering
             the study. Patients must have recovered from acute toxicities from chemotherapy or
             radiotherapy administered prior to entering this study. Alopecia may not be resolved
             and peripheral neuropathy (grade 1) may be present.

          -  Patients with reproductive potential must use an adequate contraceptive method (e.g.,
             abstinence, intrauterine device, oral contraceptives, barrier device with spermicide
             or surgical sterilization) during treatment and for three months after completing
             treatment.

          -  Ability to understand and willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Prior unanticipated severe reaction to fluoropyrimidine therapy or known
             hypersensitivity to 5-fluorouracil or oxaliplatin

          -  Patients who have had chemotherapy or radiotherapy within 4 weeks prior to first
             treatment in this study or those who have not recovered from adverse events due to
             agents administered more than 4 weeks earlier

          -  Patients receiving any other investigational agent(s)

          -  Patients with symptomatic brain metastases or actively receiving any therapy for brain
             metastasis (because of their poor prognosis and because they often develop progressive
             neurologic dysfunction that would confound the evaluation of neurologic and other
             adverse events)

          -  Active second malignancy in the last 5 years except for non-melanoma skin cancer or
             carcinoma-in-situ

          -  Clinically significant cardiac disease (e.g. congestive heart failure, New York Heart
             Association Class II or greater, symptomatic coronary artery disease and cardiac
             arrhythmias) or myocardial infarction within the last 12 months.

          -  If patient is unable to swallow, xeloda may be crushed per hospital policy/procedure.
             See attached Appendix G.

          -  Patients who have had an organ allograft.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, or psychiatric illness/social situations that would limit compliance with
             study requirements.

          -  Pregnancy

          -  Known Hepatitis B , Hepatitis C, HIV

        Inclusion of Minorities:

        Members of all ethnic groups are eligible for this trial.