Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
795 participants
Study Classification
INTERVENTIONAL
Study Start Date
2006-12-31
Study Completion Date
2010-03-31
Brief Summary
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This study will compare the effects of pemetrexed plus cisplatin versus cisplatin alone in head and neck cancer patients.
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Detailed Description
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Conditions
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Head and Neck Neoplasms
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Pemetrexed/Cisplatin
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.
Group Type
EXPERIMENTAL
pemetrexed
Intervention Type
DRUG
500 mg/m\^2, IV, every 21 days, six 21 day cycles
cisplatin
Intervention Type
DRUG
75 mg/m\^2, administered IV, every 21 days, six 21 day cycles
Placebo/Cisplatin
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.
Group Type
PLACEBO_COMPARATOR
cisplatin
Intervention Type
DRUG
75 mg/m\^2, administered IV, every 21 days, six 21 day cycles
placebo
Intervention Type
DRUG
Approximately 100 mL normal saline administered IV, every 21 days, six 21 day cycles
Interventions
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pemetrexed
500 mg/m\^2, IV, every 21 days, six 21 day cycles
Intervention Type
DRUG
cisplatin
75 mg/m\^2, administered IV, every 21 days, six 21 day cycles
Intervention Type
DRUG
placebo
Approximately 100 mL normal saline administered IV, every 21 days, six 21 day cycles
Intervention Type
DRUG
Other Intervention Names
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Alimta
LY231514
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Eli Lilly
Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Orange, California, United States
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Orlando, Florida, United States
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St. Petersburg, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Beech Grove, Indiana, United States
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Wichita, Kansas, United States
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Louisville, Kentucky, United States
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Ann Arbor, Michigan, United States
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Minneapolis, Minnesota, United States
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St Louis, Missouri, United States
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Stony Brook, New York, United States
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Chapel Hill, North Carolina, United States
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Oklahoma City, Oklahoma, United States
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North Smithfield, Rhode Island, United States
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Buenos Aires, , Argentina
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S.M. de Tucuman, , Argentina
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Santa Fé, , Argentina
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Tucumain, , Argentina
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Antwerp, , Belgium
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Edegem, , Belgium
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Belo Horizonte, , Brazil
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Rio de Janeiro, , Brazil
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Guangzhou, , China
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Nanning, , China
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Shanghai, , China
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Wuhan, , China
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Aarhus, , Denmark
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Odense, , Denmark
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Avignon, , France
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Tours, , France
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Berlin, , Germany
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Erlangen, , Germany
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Essen, , Germany
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Frankfurt, , Germany
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Hanover, , Germany
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Heidelberg, , Germany
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Leipzig, , Germany
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Lübeck, , Germany
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Budapest, , Hungary
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Nyíregyháza, , Hungary
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Bangalore, , India
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Bhopal, , India
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Hyderabaad, , India
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Jaipur, , India
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Kochi, , India
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Kolkata, , India
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New Delhi, , India
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Patna, , India
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Pune, , India
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Trivandrum, , India
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Confreria, , Italy
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Genova, , Italy
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Milan, , Italy
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Padua, , Italy
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Durango, , Mexico
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Mexico City, , Mexico
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Michoacán, , Mexico
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Monterrey, , Mexico
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Roma Sur, , Mexico
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Toluca, , Mexico
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Amsterdam, , Netherlands
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Nijmegen, , Netherlands
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Gdansk, , Poland
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Krakow, , Poland
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Olsztyn, , Poland
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Warsaw, , Poland
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San Juan, , Puerto Rico
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Oradea, , Romania
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Târgu Mureş, , Romania
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Barnaul, , Russia
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Chelyabinsk, , Russia
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Moscow, , Russia
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Murmansk, , Russia
Site Status
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Saint Petersburg, , Russia
Site Status
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Bloemfontein, , South Africa
Site Status
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Durban, , South Africa
Site Status
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Parktown, , South Africa
Site Status
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Daegu, , South Korea
Site Status
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Hwasun-Gun, , South Korea
Site Status
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Pusan, , South Korea
Site Status
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Seoul, , South Korea
Site Status
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Barcelona, , Spain
Site Status
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Madrid, , Spain
Site Status
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Murcia, , Spain
Site Status
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Pamplona, , Spain
Site Status
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Seville, , Spain
Site Status
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Valencia, , Spain
Site Status
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Changhua, , Taiwan
Site Status
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Hualien City, , Taiwan
Site Status
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Liouying/Tainan, , Taiwan
Site Status
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Taipei, , Taiwan
Site Status
Countries
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United States
Argentina
Belgium
Brazil
China
Denmark
France
Germany
Hungary
India
Italy
Mexico
Netherlands
Poland
Puerto Rico
Romania
Russia
South Africa
South Korea
Spain
Taiwan
Other Identifiers
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H3E-MC-JMHR
Identifier Type: OTHER
Identifier Source: secondary_id
8431
Identifier Type: -
Identifier Source: org_study_id
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