Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

795

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Dec 2006

Typical duration for phase_3

Geographic Reach

21 countries

94 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.2 years study duration

Study Start

First participant enrolled

December 1, 2006

Completed

19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2006

Completed

2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2006

Completed

3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

April 6, 2011

Completed

Last Updated

June 28, 2011

Status Verified

June 1, 2011

Enrollment Period

3.2 years

First QC Date

December 20, 2006

Results QC Date

March 10, 2011

Last Update Submit

June 23, 2011

Conditions

Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (1)

Overall Survival (OS)
OS duration is defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date, OS duration will be censored at the date of the participant's last contact prior to that cut-off date.
Baseline to date of death from any cause up to 36 months

Secondary Outcomes (5)

Progression-free Survival (PFS)
baseline to measured progressive disease up to 33 months
Percent of Participants With a Tumor Response (Response Rate)
Baseline to progressive disease or discontinuation of study treatment up to 11 months
Duration of Response (DoR)
time of response to progressive disease up to 24 months
Time to Treatment Worsening in Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Total Score
Baseline (</=Day 1 of first dose) and Day 1 of every subsequent cycle to 30-day post-study completion up to 33 months
Correlation Between Biomarkers and Treatment Effect
Baseline

Study Arms (2)

Pemetrexed/Cisplatin

EXPERIMENTAL

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.

Drug: pemetrexedDrug: cisplatin

Placebo/Cisplatin

PLACEBO COMPARATOR

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.

Drug: cisplatinDrug: placebo

Interventions

pemetrexedDRUG

500 mg/m\^2, IV, every 21 days, six 21 day cycles

Also known as: Alimta, LY231514

Pemetrexed/Cisplatin

cisplatinDRUG

75 mg/m\^2, administered IV, every 21 days, six 21 day cycles

Pemetrexed/CisplatinPlacebo/Cisplatin

placeboDRUG

Approximately 100 mL normal saline administered IV, every 21 days, six 21 day cycles

Placebo/Cisplatin

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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 may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (94)

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.

Orange, California, 92868, United States

Location

Orlando, Florida, 32806, United States

Location

St. Petersburg, Florida, 33708, United States

Location

Atlanta, Georgia, 30322, United States

Location

Chicago, Illinois, 60637, United States

Location

Beech Grove, Indiana, 46107, United States

Location

Wichita, Kansas, 67214, United States

Location

Louisville, Kentucky, 40202, United States

Location

Ann Arbor, Michigan, 48109, United States

Location

Minneapolis, Minnesota, 55455, United States

Location

St Louis, Missouri, 63110, United States

Location

Stony Brook, New York, 11794, United States

Location

Chapel Hill, North Carolina, 27599, United States

Location

Oklahoma City, Oklahoma, 73112, United States

Location

North Smithfield, Rhode Island, 02896, United States

Location

Buenos Aires, C1185AAT, Argentina

Location

S.M. de Tucuman, 4000, Argentina

Location

Santa Fé, 3000, Argentina

Location

Tucumain, 4000, Argentina

Location

Antwerp, 2020, Belgium

Location

Edegem, 2650, Belgium

Location

Belo Horizonte, 30140-083, Brazil

Location

Rio de Janeiro, 20231050, Brazil

Location

Guangzhou, 510060, China

Location

Nanning, 530000, China

Location

Shanghai, 200032, China

Location

Wuhan, 430030, China

Location

Aarhus, 8000, Denmark

Location

Odense, 5000, Denmark

Location

Avignon, 84082, France

Location

Tours, 37044, France

Location

Berlin, 13125, Germany

Location

Erlangen, D-91054, Germany

Location

Essen, 45122, Germany

Location

Frankfurt, D-65929, Germany

Location

Hanover, 30625, Germany

Location

Heidelberg, 69120, Germany

Location

Leipzig, 04103, Germany

Location

Lübeck, 23538, Germany

Location

Budapest, 1122, Hungary

Location

Nyíregyháza, H-4400, Hungary

Location

Bangalore, 560 029, India

Location

Bhopal, 462001, India

Location

Hyderabaad, 500034, India

Location

Jaipur, 302013, India

Location

Kochi, 682304, India

Location

Kolkata, 700053, India

Location

New Delhi, 110 029, India

Location

Patna, 801505, India

Location

Pune, 411004, India

Location

Trivandrum, 695 011, India

Location

Confreria, 12100, Italy

Location

Genova, 16132, Italy

Location

Milan, 20133, Italy

Location

Padua, 35128, Italy

Location

Durango, 34208, Mexico

Location

Mexico City, 15900, Mexico

Location

Michoacán, 58080, Mexico

Location

Monterrey, Mexico

Location

Roma Sur, 06760, Mexico

Location

Toluca, CP50180, Mexico

Location

Amsterdam, 1081 HV, Netherlands

Location

Nijmegen, 6500 HB, Netherlands

Location

Gdansk, 80-211, Poland

Location

Krakow, 31-531, Poland

Location

Olsztyn, 10-228, Poland

Location

Warsaw, 02-781, Poland

Location

San Juan, 00935, Puerto Rico

Location

Bucharest, 022328, Romania

Location

Cluj-Napoca, 3400, Romania

Location

Oradea, 3700, Romania

Location

Târgu Mureş, 540136, Romania

Location

Barnaul, 656049, Russia

Location

Chelyabinsk, 454087, Russia

Location

Moscow, 115478, Russia

Location

Murmansk, 183047, Russia

Location

Saint Petersburg, 198255, Russia

Location

Bloemfontein, 9300, South Africa

Location

Durban, 4091, South Africa

Location

Parktown, 2193, South Africa

Location

Daegu, 700-721, South Korea

Location

Hwasun-Gun, 519-809, South Korea

Location

Pusan, 609 735, South Korea

Location

Seoul, 134-791, South Korea

Location

Barcelona, 08036, Spain

Location

Madrid, 28041, Spain

Location

Murcia, 30008, Spain

Location

Pamplona, 31008, Spain

Location

Seville, 41013, Spain

Location

Valencia, 46014, Spain

Location

Changhua, 500, Taiwan

Location

Hualien City, 970, Taiwan

Location

Liouying/Tainan, 736, Taiwan

Location

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

PemetrexedCisplatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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)
Eli Lilly and Company
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

December 20, 2006

First Posted

December 22, 2006

Study Start

December 1, 2006

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

June 28, 2011

Results First Posted

April 6, 2011

Record last verified: 2011-06

Locations

ZA(3)KR(4)BE(2)IT(4)DK(2)FR(2)AR(4)PR(1)BR(2)DE(8)ME(6)HU(2)NL(2)IN(10)PL(4)RU(5)US(15)ES(6)RO(4)TW(4)CN(4)

A Study for Patients With Head and Neck Cancer

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Pemetrexed/Cisplatin

Placebo/Cisplatin

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (94)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Pemetrexed/Cisplatin

Placebo/Cisplatin

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (94)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations