Status:
COMPLETED
Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is designed to study the role of an active and well-tolerated non-platinum agent, gemcitabine, in a combination regimen with pemetrexed in the first-line treatment of advanced NSCLC. This s...
Detailed Description
Upon determination of eligibility, patients will be receive: * Pemetrexed + Gemcitabine
Eligibility Criteria
Inclusion
- To be included in this study, you must meet the following criteria:
- Histologically confirmed non-small cell bronchogenic carcinoma
- Newly diagnosed or recurrent unresectable stage III or stage IV disease
- No mixed tumors with small cell anaplastic elements
- Measurable disease
- Must not have received any prior antineoplastic chemotherapy for lung cancer
- Age \> 18 years
- Able to perform activities of daily living with little or no assistance
- Adequate bone marrow, liver and kidney
- Understand the nature of this study and give written informed consent.
Exclusion
- You cannot participate in this study if any of the following apply to you:
- Female patients who are pregnant or are lactating
- History of serious cardiovascular disease within the previous six months
- Serious active infection at the time of treatment
- Other serious underlying medical condition
- Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00193414
Start Date
May 1 2005
End Date
August 1 2009
Last Update
March 3 2022
Active Locations (1)
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1
Tennessee Oncology
Nashville, Tennessee, United States, 37203