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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2009-08-31

Brief Summary

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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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Detailed Description

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Upon determination of eligibility, patients will be receive:

* Pemetrexed + Gemcitabine

Conditions

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.

Group Type EXPERIMENTAL

Pemetrexed

Intervention Type DRUG

500mg/m2 IV over 10 min, Day 1, prior to gemcitabine

Gemcitabine

Intervention Type DRUG

1500mg/m2, 30min IV

Interventions

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Pemetrexed

500mg/m2 IV over 10 min, Day 1, prior to gemcitabine

Intervention Type DRUG

Gemcitabine

1500mg/m2, 30min IV

Intervention Type DRUG

Other Intervention Names

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Alimta Gemzar

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No