Lung Cancer Clinical Trial

Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer

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 study will serve to define the role of next generation agents in a new combination regimen in the treatment of advanced NSCLC. This combination regimen may ultimately be important in further expanding treatment options for patients while improving survival, quality of life, and symptom control compared with platinum-based combination regimens - and with acceptable toxicity.

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Full Description

Upon determination of eligibility, patients will be receive:

Pemetrexed + Gemcitabine

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Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

72

Study ID:

NCT00193414

Recruitment Status:

Completed

Sponsor:

SCRI Development Innovations, LLC

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There is 1 Location for this study

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Tennessee Oncology
Nashville Tennessee, 37203, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

72

Study ID:

NCT00193414

Recruitment Status:

Completed

Sponsor:


SCRI Development Innovations, LLC

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