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

This study has been completed.

First Received: May 28, 2003 Last Updated: April 7, 2008 History of Changes

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00061451

Purpose

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.

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: Pemetrexed Drug: Gemcitabine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	ALIMTA Plus Gemcitabine as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer: A Phase II Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride Pemetrexed Pemetrexed disodium

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	48
Study Start Date:	December 2002
Estimated Study Completion Date:	September 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061451

Locations

United States, California
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.
Palo Alto, California, United States
United States, Missouri
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.
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
United States, Montana
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.
Great Falls, Montana, United States
United States, Washington
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.
Seattle, Washington, United States

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

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)

Eli Lilly and Company

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	7213, H3E-US-JMFY
Study First Received:	May 28, 2003
Last Updated:	April 7, 2008
ClinicalTrials.gov Identifier:	NCT00061451 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Gemcitabine
Respiratory Tract Neoplasms

Neoplasms by Histologic Type
Enzyme Inhibitors
Folic Acid Antagonists
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Pemetrexed
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009