Conditions: Head and Neck Neoplasms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 795
Healthy volunteers: no

Brief summary:
This study will compare the effects of pemetrexed plus cisplatin versus cisplatin alone in head and neck cancer patients.

Detailed description:

Arms:
arm 1: Pemetrexed 500 milligrams per meter square (mg/m\^2) administered intravenously (IV) plus cisplatin 75 mg/m\^2 IV on Day 1 every 21 days. Pretreatment, Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.

Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose. arm 2: Placebo (approximately 100 mL normal saline) administered intravenously (IV) plus cisplatin 75 mg/m\^2 on Day 1 every 21 days.

Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.

Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.

Interventions: intervention 1: pemetrexed intervention 2: cisplatin intervention 3: placebo
Intervention descriptions: intervention 1: 500 mg/m\^2, IV, every 21 days, six 21 day cycles intervention 2: 75 mg/m\^2, administered IV, every 21 days, six 21 day cycles intervention 3: Approximately 100 mL normal saline administered IV, every 21 days, six 21 day cycles

Protocol document: