Pemetrexed Plus Gemcitabine as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Clinical Trial

December 20, 2010 updated by: Eli Lilly and Company

ALIMTA Plus Gemcitabine as Front-line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer: A Phase II Clinical Trial

The purposes of this study are to determine:

The safety of Pemetrexed plus Gemcitabine and any side effects that might be associated with the combination of these two drugs.
Whether Pemetrexed plus Gemcitabine can help patients with non-small cell lung cancer live longer.
Whether Pemetrexed plus Gemcitabine can make the tumor smaller or disappear, and for how long.
To see if patients feel better while taking Pemetrexed plus Gemcitabine.

Study Overview

Status

Completed

Conditions

Carcinoma, Non-Small-Cell Lung

Intervention / Treatment

Study Type

Interventional

Enrollment

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Palo Alto, California, United States
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Missouri
  - Columbia, Missouri, United States
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Kansas City, Missouri, United States
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Montana
  - Great Falls, Montana, United States
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Washington
  - Seattle, Washington, United States
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Diagnosis of Non-Small Cell Lung Cancer that can be treated with chemotherapy.
Have received no prior chemotherapy for Non-Small Cell Lung Cancer.
Have at least one measurable lesion.
Have an adequate performance status.
Sign an informed consent.

Exclusion Criteria:

A female who is pregnant or breastfeeding.
Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating Pemetrexed.
Treatment with radiation therapy within the last 4 weeks.
Brain metastasis that is uncontrolled.
Active infection or other serious condition.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To assess the objective tumor response rate of gemcitabine plus pemetrexed in patients with advanced or metastatic non-small-cell lung cancer.

Secondary Outcome Measures

Outcome Measure
To assess time to objective tumor response for responding patients
To assess duration of response for responding patients
To assess time to treatment failure for patients
To assess progression free survival of patients
To assess time to progressive disease for patients
To assess survival time for patients
To characterize the toxicities of gemcitabine plus pemetrexed in this patient population

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

May 28, 2003

First Submitted That Met QC Criteria

May 28, 2003

First Posted (Estimate)

May 29, 2003

Study Record Updates

Last Update Posted (Estimate)

December 22, 2010

Last Update Submitted That Met QC Criteria

December 20, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

7213 (Other Identifier: CTEP)
H3E-US-JMFY

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.