A Study of a New Combination and Schedule of Chemotherapy Drugs for the Treatment of Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: Docetaxel; Capecitabine
Intervention description: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule. If the subject's disease has not decreased significantly but there is no evidence the disease is getting worse, he/she will continue on the same treatment until: a) there is evidence that the treatment is no longer working to control the growth of his/her disease, b) He/she experiences unacceptable toxicity, c) his/her disease progresses, or d) he/she chooses to stop therapy.; Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule. If the subject's disease has not decreased significantly but there is no evidence the disease is getting worse, he/she will continue on the same treatment until: a) there is evidence that the treatment is no longer working to control the growth of his/her disease, b) He/she experiences unacceptable toxicity, c) his/her disease progresses, or d) he/she chooses to stop therapy.
Intervention MeSH terms: Docetaxel; Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Squamous cell cancer of the oral cavity and pharynx

Summary:

      The purpose of this study is to determine the effectiveness and side effects of a new
      combination and schedule of chemotherapy drugs in the treatment of head and neck cancer.
      Patients with advanced or recurrent head and neck cancer, which is untreatable by surgery or
      radiation therapy are eligible for this study. Standard treatment for advanced or recurrent
      head and neck cancer involves the use of chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have documented advanced, locally recurrent, or metastatic head and neck
             carcinoma, which is untreatable by surgical resection or radiation therapy.

          -  Prior chemotherapy for advanced/metastatic disease is allowed (1 regimen only).

          -  Patients must be taxane-naïve (no prior docetaxel or paclitaxel).

          -  Patients who have received chemoradiation as a primary therapy for advanced head and
             neck cancer are eligible.

          -  Patients must have measurable or evaluable disease. Pre-study imaging for disease
             assessment must be done within 28 days of registration.

          -  Patients with brain metastases are eligible if they have been stable for at least six
             weeks post-radiation therapy.

          -  Aged 18 years or older

          -  Performance status of 0-2 by Zubrod criteria.

          -  Life expectancy of at least 12 weeks.

          -  Hematologic: absolute neutrophil count (ANC) equal to or > 1,500/mm3; hemoglobin equal
             to or > 8.0 g/dl; platelets equal to or > 100,000/mm3.

          -  Total bilirubin must be within normal institutional limits (WNL).

          -  Transaminases (AST/SGOT and ALT/SGPT) may be up to 2.5 X the institutional upper limit
             of normal (ULN) if alkaline phosphatase is less than ULN, or alkaline phosphatase may
             be up to 4 X ULN if transaminases are less than ULN.

          -  A calculated creatinine clearance of > 50 ml/min

          -  Women of childbearing potential must have a negative pregnancy test at baseline, prior
             to receiving any study drug. (Pregnant or lactating patients are excluded.)

          -  Patients of reproductive potential must practice effective contraception while on
             study and for at least six months after receiving the last dose of study drug.

          -  All patients must sign an informed consent prior to enrollment.

          -  No prior history of malignancy, except for adequately treated skin cancer or in situ
             cervical carcinoma or any other cancer in complete remission for at least two years.

        Exclusion Criteria:

          -  Patients with congestive heart failure, second or third degree heart block or recent
             myocardial infarction within 12 months from registration are not eligible.

          -  Peripheral neuropathy equal to or greater than grade 2.

          -  Patients with a history of severe hypersensitivity reaction to drugs formulated with
             polysorbate 80.

          -  Use of standard chemotherapy or investigational agents for treatment of head and neck
             cancer within 28 days of 1st dose of study drug.

          -  Any medical or psychiatric illness which, in the opinion of the principal
             investigator, would compromise the patient's ability to tolerate this treatment
             regimen.

          -  Prior unanticipated severe reaction to fluoropyrimidine therapy or known
             hypersensitivity to 5-fluorouracil.

          -  Pregnant or lactating women, women of childbearing potential with either a positive
             pregnancy test (PPT) at baseline, or sexually active females not using a reliable
             contraceptive method while on study and for at least six months after chemotherapy.
             (Postmenopausal women must have been amenorrheic for at least 12 months to be
             considered of non-childbearing potential.)

          -  Sexually active patients not using a reliable contraceptive method while on study and
             for at least six months after chemotherapy.

          -  Patients with malabsorption syndromes will be excluded. Administration of capecitabine
             through feeding tubes is permitted.

          -  Serious concurrent infections.

          -  Any other serious uncontrolled medical or surgical conditions that the investigator
             feels might compromise study participation.