Docetaxel and Capecitabine in Treating Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

PRIMARY OBJECTIVES:

I. To evaluate in a phase II study the efficacy (the radiographic assessment of disease
status after 2 cycles of therapy) of a combination of docetaxel and capecitabine in subjects
with advanced squamous cell carcinoma of the head and neck who are not candidates for surgery
or radiation therapy.

II. To evaluate the safety and toxicities of docetaxel and capecitabine in subjects with
advanced squamous cell carcinoma of the head and neck.

III. To descriptively examine the effects of the combination of docetaxel and capecitabine on
the quality of life of subjects with advanced squamous cell carcinoma of the head and neck.

OUTLINE:

Patients receive docetaxel intravenously (IV) over 1 hour on day 1 and capecitabine orally
(PO) twice daily (BID) on days 1-14. Courses repeat every 21 days in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days and then
periodically thereafter.

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