Study Comparing Short Infusion Vs. Fixed Dose of Cisplatin + Gemcitabine in Non Small Cell Lung Cancer.
NCT ID: NCT00191620
Last Updated: 2007-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
64 participants
INTERVENTIONAL
2004-03-31
2006-05-31
Brief Summary
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How standard gemcitabine plus cisplatin compares to fixed dose rate of gemcitabine plus cisplatin in the treatment of non-small cell lung cancer.
The safety of standard gemcitabine plus cisplatin and any side effects that might be associated with it as compared to a fixed dose rate of gemcitabine plus cisplatin.
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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
Interventions
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Gemcitabine
cisplatin
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed diagnosis of NSCLC
* Have provided written informed consent
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Adequate organ function
Exclusion Criteria
* Presence of uncontrolled central nervous system (CNS) metastases
* Inability to comply with protocol or study procedures
* Pregnancy
* Breast feeding
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
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
Buenos Aires, , Argentina
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
São Paulo, , Brazil
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, , Chile
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
Mexico City, , Mexico
Countries
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References
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Pereira JR, Fein L, Del Giglio A, Blajman CR, Richardet E, Schwartsmann G, Orlando M, Hall BJ, West TM, van Kooten M. Gemcitabine administered as a short infusion versus a fixed dose rate in combination with cisplatin for the treatment of patients with advanced non-small cell lung cancer. Lung Cancer. 2007 Oct;58(1):80-7. doi: 10.1016/j.lungcan.2007.05.004. Epub 2007 Jun 22.
Other Identifiers
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B9E-LA-S350
Identifier Type: -
Identifier Source: secondary_id
6952
Identifier Type: -
Identifier Source: org_study_id
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