Docetaxel, Cisplatin and Fluorouracil in Treating Participants With Previously Untreated Stage II-IV Nasal Cavity and Paranasal Sinus Cancer

PRIMARY OBJECTIVES:

I. To determine the clinical/radiographic complete and partial response rate after induction
chemotherapy with docetaxel, cisplatin and fluorouracil (TPF).

II. To improve local tumor control to 80% at 2 years.

SECONDARY OBJECTIVES I. Disease specific-survival and overall survival rates. II. Organ
preservation (orbital, maxillary, cranial) rate. III. Patterns of treatment failure (local,
regional, and distant). IV. Acute and late treatment-related toxicity. V. The effect of
treatment on Quality of Life with and without surgery (i.e., M. D. Anderson Symptom Inventory
[MDASI], M. D. Anderson Dysphagia Inventory [MDADI], Xerostomia Questionnaire, Performance
Status Scale for Head & Neck Cancer Patients [PSS-HN], etc.).

VI. To evaluate the effects of induction chemotherapy on biological markers that could serve
as surrogates for response and predictors of long-term outcome.

OUTLINE:

INDUCTION CHEMOTHERAPY: Participants receive docetaxel intravenously (IV) over 1 hour on day
1, cisplatin IV over 30-180 minutes or carboplatin IV on day 1, and fluorouracil IV
continuously on days 1-4. Courses repeat every 3 weeks for up to 2 courses in the absence of
disease progression or unacceptable toxicity.

Participants who achieve complete response (CR) or partial response (PR) receive 1 additional
course of treatment and undergo chemoradiotherapy over 6-7 weeks. Participants who have
stable disease (SD) or progressive disease (PD) to induction therapy, or less than a complete
response to chemoradiotherapy undergo surgery and radiation therapy.

After completion of study treatment, participants are followed up every 3 months for 2 years,
every 4 months for 1 year and every 6 months for 2 years.

Inclusion Criteria:

- Patients must have a confirmed (by a MD Anderson Cancer Center [MDACC] pathologist)
cytologic or histological diagnosis of locally advanced squamous cell carcinoma,
poorly differentiated carcinoma, or sinonasal undifferentiated carcinoma of the nasal
cavity and/or paranasal sinuses.

- Stage II-IV disease; tumor (T) 2-4, node (N) any, metastasis (M) 0. Measurable disease
is required with the following criteria: Measurable lesions can be accurately
measured, with at least one diameter >= 1.0 cm by spiral computed tomography (CT) scan
or magnetic resonance imaging (MRI). Lesions can be bidimensionally measurable or
unidimensionally measurable. Every effort should be made to measure lesions in two
dimensions. Measurable disease is present if the patient has one or more measurable
lesions. Non-measurable lesions/disease are all other lesions, including small lesions
(those with measurements < 2.0 cm; or < 1.0 cm with spiral CT).

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1.

- Absolute peripheral granulocyte count (AGC) of >= 1500 cells/mm3.

- Platelet count of >= 100,000 cells/mm3.

- Total bilirubin =< upper limit of normal (ULN). If the patient has a history of
Gilbert's Syndrome, check direct and indirect bilirubin. If in the judgment of the
attending medical oncologist it is safe to treat the patient, the patient will be
considered eligible for this criteria.

- Alkaline phosphatase =< 2 x ULN. If in the judgment of the attending medical
oncologist it is safe to treat the patient, the patient will be considered eligible
for this criteria.

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2 x ULN. If in
the judgment of the attending medical oncologist it is safe to treat the patient, the
patient will be considered eligible for this criteria.

- Hemoglobin >= 10.0g/dL.

- Per MDACC creatinine clearance (CrCl) guidelines, patients must have a creatinine
clearance > 50 ml/min determined by 24 hour collection or nomogram

- Patients should have uncontrolled intercurrent illness, which in the opinion of the
attending medical oncologist, would render the patient unsuitable for the study (i.e.,
preclude safe administration of the prescribed chemotherapy treatment).

- Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy
test (i.e., minimum sensitivity 25 IU/L or equivalent units of human chorionic
gonadotropin [HCG]), within 72 hours prior to the start of study treatment. Should a
woman become pregnant or suspect she is pregnant while participating in the study, she
should inform her treating physician(s) immediately.

- Ability to understand and the willingness to sign a written Informed Consent Document
(ICD). In the event that non-English speaking participants are eligible for this
study, a short form (if applicable) or an ICD in their language, will be utilized and
completed in accordance with the MDACC Policy For Consenting Non-English Speaking
Participants.

- Willingness to undergo MDACC Audiology and Ophthalmology Assessment.

Exclusion Criteria:

- Evidence of distant metastases (below the clavicle) by clinical or radiographic
measures.

- Pre-existing peripheral neuropathy Common Terminology Criteria for Adverse Events
(CTCAE) grade 2 or worse.

- Pre-existing bilateral sensorineural hearing loss at > 90dB at any frequency from
250-8000Hz as assessed by a comprehensive audiometric evaluation for patients
receiving cisplatin. This criteria will not apply to patients receiving carboplatin.

- Prior chemotherapy (i.e., as administered strictly for cancer treatment) within the
previous 3 years. Use of chemotherapy agents for non-cancer treatment purposes (i.e.,
arthritis treatment, etc.) are excluded from this criterion.

- Prior radiotherapy to the paranasal sinus region or the upper neck (i.e., prior
radiotherapy to another disease site is acceptable).

- Initial surgical resection of the paranasal sinuses or nasal cavity region rendering
the patient clinically and radiologically disease free.

- Simultaneous primary invasive cancers or patients currently receiving any other
investigational agents at time of study enrollment. Patients may have received
investigational agents in the past. No washout time period is required.

- Patients with a past history of malignancy that were treated less than 3 years and
have not remained disease free for the past 3 years. (Patients with non metastatic
skin cancers will be eligible).

- Men and women of childbearing potential (WOCBP) who are unwilling or unable to use an
acceptable method to avoid pregnancy for the entire study period and for up to 3
months after the study. Subjects who are men must also agree to use effective
contraception. Note: WOCBP must be using an adequate method of contraception
throughout the study and for up to 3 months after the study. Adequate methods of
contraception will include (oral, injectable, or implantable hormonal contraceptive;
tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or
vasectomized partner).

- Women who are pregnant or breastfeeding.

- Patients with a history of severe hypersensitivity reaction to docetaxel or other
drugs formulated with polysorbate 80.

- Patients with a known history of human immunodeficiency virus (HIV).