Pemetrexed and Gemcitabine in Patients With Advanced Head and Neck Cancer

Exclusion Criteria

• •Serious concomitant systemic disorder that would compromise safety or ability to complete study.
• •Prior treatment with gemcitabine or pemetrexed within the previous year, unless used concurrently with radiation therapy.
• •Pregnancy or breastfeeding.
• •Symptomatic or uncontrolled brain mets. If treated, must be off steroids for at least 2 weeks.
• •Inability or unwilling to take folic acid, vitamin B12, or dexamethasone.
• •Treatment within last 30 days with a drug that has not received regulatory approval for any indication.
• •Inability to interrupt and NSAID or salicylate with a long half-life (piroxicam or nabumetone) for a 5 day period.
• •Presence of clinically relevant third space fluid that cannot be controlled by drainage or other procedure prior to study entry.
• •Active, concurrent, invasive malignancy requiring ongoing treatment.
• •Corticosteroids impermissible unless for adrenal failure, septic shock or as temporizing measure for symptomatic pain, breathing, or rash.