Clinical trial NCT00415194: A Study for Patients With Head and Neck Cancer
Official title: A Randomized Phase 3 Study of Pemetrexed in Combination With Cisplatin Versus Cisplatin Monotherapy in Patients With Recurrent or Metastatic Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Head and Neck Neoplasms
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2006-12-22
Enrollment: 795
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Baseline to date of death from any cause up to 36 months
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: baseline to measured progressive disease up to 33 months
measure: Percent of Participants With a Tumor Response (Response Rate)
timeFrame: Baseline to progressive disease or discontinuation of study treatment up to 11 months
measure: Duration of Response (DoR)
timeFrame: time of response to progressive disease up to 24 months
measure: Time to Treatment Worsening in Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Total Score
timeFrame: Baseline (</=Day 1 of first dose) and Day 1 of every subsequent cycle to 30-day post-study completion up to 33 months
measure: Correlation Between Biomarkers and Treatment Effect
timeFrame: Baseline
Other outcomes:
Locations:
city: Orange
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: Orlando
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Florida
city: St. Petersburg
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Florida
city: Atlanta
country: United States
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state: Georgia
city: Chicago
country: United States
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state: Illinois
city: Beech Grove
country: United States
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state: Indiana
city: Wichita
country: United States
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state: Kansas
city: Louisville
country: United States
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state: Kentucky
city: Ann Arbor
country: United States
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state: Michigan
city: Minneapolis
country: United States
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state: Minnesota
city: St Louis
country: United States
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state: Missouri
city: Stony Brook
country: United States
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state: New York
city: Chapel Hill
country: United States
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state: North Carolina
city: Oklahoma City
country: United States
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state: Oklahoma
city: North Smithfield
country: United States
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state: Rhode Island
city: Buenos Aires
country: Argentina
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city: S.M. De Tucuman
country: Argentina
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city: Santa Fé
country: Argentina
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city: Tucumain
country: Argentina
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city: Antwerp
country: Belgium
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city: Edegem
country: Belgium
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city: Belo Horizonte
country: Brazil
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city: Rio De Janeiro
country: Brazil
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city: Guang Zhou
country: China
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city: Nanning
country: China
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city: Shanghai
country: China
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city: Wu Han
country: China
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city: Aarhus
country: Denmark
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city: Odense
country: Denmark
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city: Avignon
country: France
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city: Tours
country: France
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city: Berlin
country: Germany
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city: Erlangen
country: Germany
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city: Essen
country: Germany
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city: Frankfurt
country: Germany
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city: Hannover
country: Germany
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city: Heidelberg
country: Germany
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city: Leipzig
country: Germany
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city: Luebeck
country: Germany
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city: Budapest
country: Hungary
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city: Nyiregyhaza
country: Hungary
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city: Bangalore
country: India
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city: Bhopal
country: India
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city: Hyderabaad
country: India
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city: Jaipur
country: India
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city: Kochin
country: India
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city: Kolkata
country: India
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city: New Delhi
country: India
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city: Patna
country: India
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city: Pune
country: India
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city: Trivandrum
country: India
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city: Confreria
country: Italy
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city: Genova
country: Italy
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city: Milano
country: Italy
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city: Padova
country: Italy
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city: Daegu
country: Korea, Republic of
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city: Hwasun-Gun
country: Korea, Republic of
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city: Pusan
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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city: Durango
country: Mexico
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city: Mexico City
country: Mexico
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city: Michoacan
country: Mexico
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city: Monterrey
country: Mexico
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city: Roma Sur
country: Mexico
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city: Toluca
country: Mexico
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city: Amsterdam
country: Netherlands
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city: Nijmegen
country: Netherlands
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city: Gdansk
country: Poland
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city: Krakow
country: Poland
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city: Olsztyn
country: Poland
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city: Warsaw
country: Poland
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city: San Juan
country: Puerto Rico
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city: Bucharest
country: Romania
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city: Cluj-Napoca
country: Romania
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city: Oradea
country: Romania
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city: Targu Mures
country: Romania
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city: Barnaul
country: Russian Federation
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city: Chelyabinsk
country: Russian Federation
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city: Moscow
country: Russian Federation
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city: Murmansk
country: Russian Federation
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city: Saint Petersburg
country: Russian Federation
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city: Bloemfontein
country: South Africa
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city: Durban
country: South Africa
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city: Parktown
country: South Africa
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city: Barcelona
country: Spain
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city: Madrid
country: Spain
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city: Murcia
country: Spain
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city: Pamplona
country: Spain
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city: Sevilla
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Valencia
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Changhua
country: Taiwan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Hualien
country: Taiwan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Liouying/Tainan
country: Taiwan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Taipei
country: Taiwan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: