Docetaxel and Capecitabine With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Condition: Head and Neck Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Capecitabine; Docetaxel; Quality-of-Life Assessment; Questionnaire Administration
Intervention description: Given PO; Given IV; Ancillary studies; Ancillary studies
Intervention MeSH terms: Docetaxel; Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies the side effects and how well docetaxel and capecitabine work in
      treating patients with squamous cell (thin, flat cells) carcinoma of the head and neck that
      has come back or spread to other places in the body. Drugs used in chemotherapy, such as
      docetaxel and capecitabine, work in different ways to stop the growth of tumor cells, either
      by killing the cells, by stopping them from dividing, or by stopping them from spreading.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven squamous cell carcinoma of the head and neck with measurable
             disease that is either recurrent after attempted cure with surgery and/or radiation
             therapy or newly diagnosed disease with distant metastases or incurable at diagnosis

          -  Performance status: Karnofsky score >= 70 or Eastern Cooperative Oncology Group (ECOG)
             0-2

          -  Age 19 years or older (age of consent in Nebraska); age 18 years or older (applicable
             to states where the age of majority is 18)

          -  No prior chemotherapy for metastatic squamous cell carcinoma of the head and neck;
             subjects who have received chemotherapy as part of a multi-modality curative approach
             for head and neck cancer will be eligible as long as they have not received either
             docetaxel or capecitabine (or fluorouracil [5-FU]) as part of that regimen

          -  White blood cell (WBC) count >= 3,500/mm^3

          -  Platelet count >= 100,000/mm^3

          -  Serum creatinine less than 1.5 times the upper limits of normal

          -  Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than
             1.5 times the upper limits of normal

          -  Serum alkaline phosphatase less than 2.5 times the upper limits of normal

          -  Serum total bilirubin is less than or equal to the upper limits of normal

          -  Prothrombin time (PT) or international normalized ratio (INR), and partial
             thromboplastin time (PTT) =< 1.5 x upper limit of normal unless subject is receiving
             anticoagulants; if the subject is on anticoagulation therapy, levels should be within
             therapeutic range

          -  Women of reproductive potential must be non-pregnant and non-nursing and must agree to
             employ an effective barrier method of birth control throughout the study and for up to
             6 months following treatment

          -  Women of child-bearing potential must have a negative pregnancy test within 7 days of
             initiating study; (no childbearing potential is defined as age 55 years or older and
             no menses for two years or any age with surgical removal of the uterus and/or both
             ovaries)

          -  The subject must be aware of the neoplastic nature of his/her disease and willingly
             provide written, informed consent after being informed of the procedure to be
             followed, the experimental nature of the therapy, alternatives, potential benefits,
             side-effects, risks, and discomforts

        Exclusion Criteria:

          -  Prior chemotherapy for metastatic squamous cell carcinoma of the head and neck;
             subjects who have received chemotherapy as part of a multi-modality curative approach
             for head and neck cancer will be eligible as long as they have not received either
             docetaxel or capecitabine (or 5-FU) as part of that regimen

          -  Allergy to either of the study medications or 5-fluorouracil

          -  Simultaneous participation in other therapeutic clinical trials will not be allowed

          -  If a subject is receiving allopurinol/cimetidine/antivirals they must be discontinued
             prior to starting this protocol

          -  Prior malignancy, except for adequately treated basal cell or squamous cell carcinoma
             of the skin, or thyroid cancer; carcinoma in situ of the cervix or breast; prostate
             cancer of Gleason grade 6 or less with stable prostate-specific antigen (PSA) levels
             (gonadotropin-releasing hormone [GnRH] analogs or androgen receptor blockers
             acceptable); or other cancers from which the subject has been disease-free for at
             least five years

          -  Uncontrolled intercurrent illnesses including, but not limited to symptomatic
             congestive heart failure, severe oxygen dependent chronic obstructive pulmonary
             disease, unstable angina or uncontrolled cardiac arrhythmia that could jeopardize the
             subject?s ability to receive the chemotherapy described in the protocol safely

          -  Pregnant and nursing women are excluded from this study

          -  Inability to co-operate with the study visit schedule and other requirements of the
             protocol

          -  Any other clinically significant medical disease or condition laboratory abnormality
             or psychiatric illness that, in the Investigator?s opinion, may interfere with
             protocol adherence or a subject?s ability to give informed consent