Status:
COMPLETED
A Study of Pemetrexed/Cisplatin as Pre-operative Treatment of Early Stage Nonsquamous Non-Small Cell Lung Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this trial is to assess how well the combination of pemetrexed with cisplatin can reduce tumor size.
Eligibility Criteria
Inclusion
- Nonsquamous Non-Small Cell Lung Cancer that was confirmed by tissue biopsy
- 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
- Receiving or have received an investigational drug or device within the last 30 days
- Have previously completed or withdrawn from this study or any other study investigating pemetrexed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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01165021
Start Date
November 1 2010
End Date
April 1 2016
Last Update
September 25 2019
Active Locations (7)
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1
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, 20133
2
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, 28100
3
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, 10043
4
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, 35100