Induction Therapy-Docetaxel, Cisplatin and Fluorouracil in Untreated Advanced Squamous Cell or Undifferentiated Carcinoma of the Paranasal Sinuses

Inclusion Criteria:

1. Within 12 weeks prior to study entry, patients must have a confirmed cytologic or histological diagnosis of locally advanced squamous cell carcinoma and/or poorly differentiated carcinoma of the nasal cavity and/or paranasal sinuses. If the biopsy was collected outside of MDACC, the MDACC Pathology Department must assess and confirm the SCC diagnosis.
2. 2. Stage II-IV disease; T 2-4, N any, M0. Measurable disease is required with the following criteria: Measurable lesions can be accurately measured, with at least one diameter >\= 1.0 cm by spiral CT scan or 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).
3. Karnofsky performance status of >/= 70 or ECOG PS 0-1.
4. Age > 16 years.
5. Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of >/= 1500 cells/mm3 and platelet count of >/= 100,000 cells/mm3;
6. Hepatic Parameters: Total Bilirubin </= ULN AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used. **Refer to table in protocol pg. 10**
7. Hemoglobin >/= 10.0g/dL
8. Per MDACC Creatinine clearance guidelines, patients must have a Creatinine clearance > 50 ml/min determined by 24 hour collection or nomogram: CrCl male = (140 - age) x (wt in kg)/serum Cr x 72 CrCl female = 0.85 x (CrCl male)
9. Patients should have no substantial concomitant medical 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).
10. 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 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. **Refer to pg. 10 of the protocol for the formal definition of a WOCBP.**
11. 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.
12. Willingness to undergo MDACC Audiology and Ophthalmology Assessment

Exclusion Criteria:

1. Histology other than locally advanced squamous cell carcinoma and/or poorly differentiated carcinoma of the nasal cavity and paranasal sinuses.
2. Evidence of distant metastases (below the clavicle) by clinical or radiographic measures.
3. Karnofsky performance status < 70 or ECOG>1 (Appendices B and BB).
4. Pre-existing peripheral neuropathy CTCAE grade 2 or worse or pre-existing severe bilateral hearing deficits.
5. 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.
6. Prior radiotherapy to the paranasal sinus region or the upper neck (i.e., prior radiotherapy to another disease site is acceptable).
7. Initial surgical resection of the paranasal sinuses or nasal cavity region rendering the patient clinically and radiologically disease free.
8. 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.
9. Patients with a past history of malignancy (excluding non melanoma skin cancers, and cancers treated > 3 years prior for which patient remains continuously disease free).
10. 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).
11. Women who are pregnant or breastfeeding.
12. Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80. Please refer to Study Appendix O for a complete list of Polysorbate 80 containing drugs.
13. Patients with a history of HIV or Hepatitis C.