A Randomized Phase 3 Study of Pemetrexed in Combination With Cisplatin Versus Cisplatin Monotherapy in Patients With Recurrent or Metastatic Head and Neck Cancer

Inclusion Criteria:

- You must have head and neck cancer that has returned and cannot be treated with
surgery or other types of treatment. OR You must have head and neck cancer that was
just found and has spread to other parts of your body.

- You must have a performance status of 0,1 or 2. This means that you must at least be
able to get around, be able to take care of yourself and must be up and about most of
the day.

- Your test results must show that your liver, kidneys and blood cells are working
normally.

- You must understand and sign the form that gives your agreement to willingly be part
of the study.

- You must be at least 18 years of age.

Exclusion Criteria:

- You cannot have previously been given other treatment for cancer that has spread to
other parts of your body.

- You cannot have a serious sickness that might keep you from finishing the study (for
example a bad infection).

- You cannot have any extra fluid in your chest or bowel area unless your doctor tells
you it can be drained before you join the study.

- You cannot have any cancer called nasopharyngeal cancer, paranasal sinus cancer, lip
cancer, or salivary gland cancer.

- If you are taking high dose aspirin or other medicines called non-steroidal
anti-inflammatory drugs and cannot stop taking them for at least 5 days, you cannot
be in the study. Your doctor or a member of the study team can explain which drugs
are non-steroidal anti-inflammatory drugs.