Lung Cancer Clinical Trial

A Randomized Phase 3 Trial of Pemetrexed and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

Summary

This study is a randomized Phase 3 study comparing pemetrexed and cisplatin combination to gemcitabine and cisplatin for the treatment of Non Small Cell Lung Cancer (NCSLC). Gemcitabine plus cisplatin is currently the standard of care for NSCLC. It is thought that pemetrexed plus cisplatin may be as effective and may have fewer side effects than the standard of care.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosis of NSCLC Stage IIIB not amenable to curative treatment or Stage IV.
No prior chemotherapy for lung cancer.
Patients must have at least one uni-dimensionally measurable lesion.
Prior radiation therapy to less than 25% of bone marrow, whole pelvis not allowed. Radiation must be completed at least 4 weeks prior to study enrollment.

Exclusion Criteria:

Treatment with any drug within the last 30 days that has not received regulatory approval.
Serious cardiac condition.
Serious medical disorder in addition to NSCLC that would make it difficult for the patient to complete the study.
Inability or unwillingness to take folic acid or Vitamin B12 supplementation.
Presence of fluid retention that cannot be controlled by drainage.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

1713

Study ID:

NCT00087711

Recruitment Status:

Completed

Sponsor:

Eli Lilly and Company

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There is 1 Location for this study

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Sacramento California, , United States
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Torrance California, , United States
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Jacksonville Florida, , United States
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Macon Georgia, , United States
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Wichita Kansas, , United States
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Lexington Kentucky, , United States
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Scarborough Maine, , United States
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Duluth Minnesota, , United States
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Saint Louis Missouri, , United States
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Billings Montana, , United States
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Hackensack New Jersey, , United States
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Hickory North Carolina, , United States
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Portland Oregon, , United States
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Columbia South Carolina, , United States
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Nashville Tennessee, , United States
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Arlington Texas, , United States
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Richmond Virginia, , United States
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Seattle Washington, , United States
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Bahia Blanca , , Argentina
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Buenos Aires , , Argentina
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Bedford Park , , Australia
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Camperdown , , Australia
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Chermisdie , , Australia
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Fitzroy , , Australia
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Hornsby , , Australia
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Nedlands , , Australia
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South Brisbane , , Australia
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St Leonards , , Australia
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Graz , , Austria
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Grimmenstein , , Austria
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Innsbruck , , Austria
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Leoben , , Austria
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Linz , , Austria
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St. Poelten , , Austria
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Vienna , , Austria
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Wels , , Austria
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Leuven , , Belgium
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Liege , , Belgium
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Florianopolis , , Brazil
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Porto Alegre , , Brazil
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Rio De Janeiro , , Brazil
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Salvador , , Brazil
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Sao Paulo , , Brazil
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North Vancouver British Columbia, , Canada
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Brampton Ontario, , Canada
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Toronto Ontario, , Canada
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Sainte-Foy Quebec, , Canada
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Herlev , , Denmark
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Odense , , Denmark
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Helsinki , , Finland
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Tampere , , Finland
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Bordeaux , , France
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Grenoble , , France
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Marseille , , France
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Montpellier , , France
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Paris , , France
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Saint Herblain , , France
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Strasbourg , , France
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Vandoeuvre-les-Nancy , , France
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Mannheim , , Germany
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Athens , , Greece
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Heraklion , , Greece
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Patras , , Greece
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Budapest , , Hungary
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Deszk , , Hungary
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Pecs , , Hungary
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Bangalore , , India
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Cochin , , India
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Hyderabad , , India
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Mumbai , , India
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New Dehli , , India
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Pune , , India
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Kfar Saba , , Israel
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Tel-Aviv , , Israel
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Tel-Hashomer , , Israel
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Ancona , , Italy
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Bergamo , , Italy
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Bologna , , Italy
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Forli , , Italy
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Genova , , Italy
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Livorno , , Italy
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Modena , , Italy
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Orbassano , , Italy
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Roma , , Italy
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Taormina , , Italy
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Goyang-Si , , Korea, Republic of
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Seoul , , Korea, Republic of
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Ciudad Obregon , , Mexico
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Guadalajara , , Mexico
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Leon , , Mexico
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Mexicali , , Mexico
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Mexico City , , Mexico
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Alkmaar , , Netherlands
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Amstelveen , , Netherlands
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Amsterdam , , Netherlands
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Arnhem , , Netherlands
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Den Bosch , , Netherlands
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Eindhoven , , Netherlands
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Harderwijk , , Netherlands
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Heerlen , , Netherlands
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Krakow , , Poland
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Lodz , , Poland
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Szczecin-Zdunowo , , Poland
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Warszawa , , Poland
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Coimbra , , Portugal
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Lisboa , , Portugal
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Porto , , Portugal
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Santa Maria Da Feira , , Portugal
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San Juan , , Puerto Rico
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Alicante , , Spain
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Badalona , , Spain
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Barcelona , , Spain
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Madrid , , Spain
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Pamplona , , Spain
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Sabadell , , Spain
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Santander , , Spain
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Zaragoza , , Spain
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Goteborg , , Sweden
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Lund , , Sweden
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Stockholm , , Sweden
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Niao Sung Hsiang , , Taiwan
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Taichung , , Taiwan
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Taipei , , Taiwan
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Tao-Yuan , , Taiwan
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Ankara , , Turkey
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Antalya , , Turkey
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Istanbul , , Turkey
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Izmir , , Turkey
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Aberdeen , , United Kingdom
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Bangor , , United Kingdom
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Chelmsford , , United Kingdom
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Fulham , , United Kingdom
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Plymouth , , United Kingdom
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Sutton , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

1713

Study ID:

NCT00087711

Recruitment Status:

Completed

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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