Pemetrexed and Oxaliplatin in Treating Patients With Locally Advanced Head and Neck Cancer

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 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 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.