A Study of Pemetrexed/Cisplatin as Pre-operative Treatment of Early Stage Nonsquamous Non-Small Cell Lung Cancer
NCT ID: NCT01165021
Last Updated: 2019-09-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
19 participants
INTERVENTIONAL
2010-11-30
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pemetrexed + Cisplatin
Pemetrexed
500 milligram per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles
Cisplatin
75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles
Folic Acid
Administered orally.
Vitamin B12
Administered Intramuscular injection.
Dexamethasone
Administered orally.
Interventions
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Pemetrexed
500 milligram per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles
Cisplatin
75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles
Folic Acid
Administered orally.
Vitamin B12
Administered Intramuscular injection.
Dexamethasone
Administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stage IIIAN2 disease (T1aN2, T1bN2, T2aN2, T2bN2, and T3N2)
* Tumor considered potentially resectable
* Good performance status (score of 0 or 1) according to Eastern Cooperative Oncology Group scale (ECOG)
* No prior therapy for lung cancer
* Measurable disease according to version 1.1 of Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
* Life expectancy of at least 6 months
* Organs are functioning well (bone marrow reserve, liver, kidney, lung)
* Signed Informed Consent
* Women must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen (for example, intrauterine device, birth control pills, or barrier device) during and for 6 months after last dose of study drug; must have a negative pregnancy test within 7 days before study enrollment; and must not be breast-feeding.
* Men must be surgically sterile, or compliant with a contraceptive regimen during and for 6 months after last dose of study drug.
* Be fit for surgery at the time of enrollment
Exclusion Criteria
* Have previously completed or withdrawn from this study or any other study investigating pemetrexed
* Serious concomitant systemic disorder
* Serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease
* Receiving concurrent administration of any other anticancer therapy
* Have received a recent (within 30 days of enrollment) or are receiving concurrent yellow fever vaccination
* Inability or unwillingness to take Pemetrexed supplementation/premedication (folic acid, vitamin B12, or corticosteroids)
* Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose less than or equal to 1.3 grams per day
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_DIRECTOR
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.
Milan, , Italy
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.
Novara, , Italy
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.
Orbassano, , Italy
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.
Padua, , Italy
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.
Pisa, , Italy
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.
Rome, , Italy
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.
Sondalo, , Italy
Countries
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Other Identifiers
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H3E-EW-JMIP
Identifier Type: OTHER
Identifier Source: secondary_id
13621
Identifier Type: -
Identifier Source: org_study_id
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