A Study for Patients With Head and Neck Cancer

Lilly

Status and phase: Completed; Phase 3

Conditions: Head and Neck Neoplasms

Treatments: Drug: placebo; Drug: pemetrexed; Drug: cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00415194

8431

H3E-MC-JMHR (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 795 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

795 participants in 2 patient groups, including a placebo group

Pemetrexed/Cisplatin

Experimental group

Description:

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.

Treatment:

Drug: pemetrexed

Drug: cisplatin

Placebo/Cisplatin

Placebo Comparator group

Description:

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.

Treatment:

Drug: placebo

Drug: cisplatin