Phase II Trial: Efficacy and Toxicity of Induction Pemetrexed (ALIMTA) and Oxaliplatin (ELOXATIN) in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

Patients must meet all of the following criteria in order to be eligible for entry into
the trial:

- Histologically or cytologically confirmed stage III - IVB HNSCC (includes unknown
primary and ParaNasal Sinus cancers)but excludes nasopharyngeal, salivary gland or
skin primaries (No TNM staging required)

- Patients must have a measurable disease defined by RECIST criteria

- Age > 18 years

- ECOG Performance Score of 0, 1 or 2

- Adequate bone marrow as evidenced by:

- Absolute neutrophil count > 1,500/μL

- Platelet count > 100,000/μL

- Adequate renal function as evidenced by serum creatinine < 1.5 mg/dL and CrCl > 45
mL/min as determined by calculated creatinine clearance using the Cockroft-Gault
formula:

- CrCl = (140-age) x (weight in kg)/72 x serum creatinine

- Multiply by 0.85 (85%) for females

- Adequate hepatic function as evidenced by:

- Serum total bilirubin < 1.5 mg/dL

- Alkaline phosphatase < 3X the ULN for the reference lab

- SGOT/SGPT < 3X the ULN for the reference lab

- Patients or their legal representatives must be able to read, understand and provide
informed consent to participate in the trial.

- Patients of childbearing potential and their partners must agree to use an effective
form of contraception during the study and for 90 days following the last dose of
study medication (an effective form of contraception is an oral contraceptive, double
barrier method or surgical intervention resulting in sterility).

- Patients must be able to interupt NSAIDs at 2 days before (5 days for long-acting
NSAIDs),the day of, and 2 days following administration of Pemetrexed.

- Patients must be willing and able to take Folic Acid (350-1000 μg) daily beginning 1
week (7 days) prior to the first dose of Pemetrexed and continued daily until 3 weeks
after the last dose of study therapy. In addition, patients must be willing to
maintain a Pill Diary as part of study compliance.

- Patients must be willing and able to take Vitamin B12 (1000 μg) administered
intramuscularly beginning 1 week (7 days) prior to the first dose of Pemetrexed and
repeated at the planned End of Treatment visit (no later than 9 weeks from the first
injection).

- Patients must be willing and able to take Dexamethasone (4 mg of oral or equivalent)
that should be given twice daily on the day before, the day of, and the day after
each dose of Pemetrexed for rash prophylaxis unless medically contraindicated.

Exclusion Criteria:

A patient may not be enrolled in the trial if any of the following criteria are met:

- Patients with an active infection or with a fever > 101.30 F within 3 days of the
first scheduled day of protocol treatment

- History of prior malignancy within the past 3 years except for curatively treated
basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized
prostate cancer with a current PSA of < 1.0 mg/dL on 2 successive evaluations, at
least 3 months apart, with the most recent evaluation no more than 4 weeks prior to
entry

- Patients with known hypersensitivity to any of the components of Oxaliplatin and
Pemetrexed

- Patients who received any chemotherapy, radiation therapy or surgical resection other
than diagnostic biopsies for HNSCC prior to the first scheduled day of protocol
treatment

- Patients who are receiving concurrent investigational therapy or who have received
investigational therapy within 30 days of the first scheduled day of protocol
treatment(investigational therapy is defined as treatment for which there is
currently no regulatory authority approved indication)

- Peripheral neuropathy ≥ Grade 2

- Patients who are pregnant or lactating

- Any other medical condition, including mental illness or substance abuse, deemed by
the Investigator to be likely to interfere with a patient's ability to sign informed
consent,cooperate and participate in the study, or interferes with the interpretation
of the results.

- History of allogeneic transplant

- Known HIV (active, previously treated or both)

- Presence of clinically detectable (by physical exam) third-space fluid collections,
for example, ascites or pleural effusions that cannot be controlled by drainage or
other procedures prior to study entry.