Feasibility Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Treatment of Non-Small Cell Lung Cancer
NCT ID: NCT00269152
Last Updated: 2015-08-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
122 participants
INTERVENTIONAL
2005-12-31
2013-07-31
Brief Summary
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A two-stage design will be employed independently for both treatment arms, with the possibility of stopping each treatment early for lack of feasibility.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A: Pemetrexed + Cisplatin
pemetrexed
500 milligrams per square meter (mg/m\^2), intravenous (IV), every 21 days x 4 cycles
cisplatin
75 mg/m\^2, intravenous (IV), every 21 days x 4 cycles
B: Pemetrexed + Carboplatin
pemetrexed
500 milligrams per square meter (mg/m\^2), intravenous (IV), every 21 days x 4 cycles
carboplatin
area under the curve (AUC) 5 milligrams per milliliter\*minute (mg/ml\*min), intravenous (IV), every 21 days x 4 cycles
Interventions
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pemetrexed
500 milligrams per square meter (mg/m\^2), intravenous (IV), every 21 days x 4 cycles
cisplatin
75 mg/m\^2, intravenous (IV), every 21 days x 4 cycles
carboplatin
area under the curve (AUC) 5 milligrams per milliliter\*minute (mg/ml\*min), intravenous (IV), every 21 days x 4 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have complete tumor resection by pneumonectomy or lobectomy
* Must have been surgically proven to be N2 negative
Exclusion Criteria
* Post-operative complications or other surgery related conditions
* A prior malignancy other than NSCLC unless that malignancy was diagnosed and treated at least 5 years ago
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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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_CHAIR
Eli Lilly and Company
Locations
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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) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bordeaux, , France
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.
Paris, , France
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.
Rennes, , France
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Saint-Priest-en-Jarez, , France
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Toulouse, , France
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Bad Berka, , Germany
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.
Bielefeld, , Germany
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Cologne, , Germany
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Großhansdorf, , Germany
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Halle, , Germany
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Hanover, , Germany
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Kassel, , Germany
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Löwenstein, , Germany
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Mainz, , Germany
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Mannheim, , Germany
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Barcelona, , Spain
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.
Madrid, , Spain
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.
Santiago de Compostela, , Spain
Countries
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Other Identifiers
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H3E-SB-S089
Identifier Type: OTHER
Identifier Source: secondary_id
10105
Identifier Type: -
Identifier Source: org_study_id
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