Pemetrexed Plus Gemcitabine for Patients With Locally Advanced or Metastatic NSCLC Who Have Not Had Previous Chemotherapy. - Full Text View

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

MedlinePlus related topics:

Cancer Lung Cancer

ChemIDplus related topics:

Gemcitabine hydrochloride Gemcitabine Pemetrexed disodium Pemetrexed

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, 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

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

To determine the tumor response rate for pemetrexed plus gemcitabine in patients with locally advanced or metastatic (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC).

Secondary Outcome Measures:

To measure time-to-event efficacy variables including:
time to objective tumor response for responding patients
duration of response for responding patients
time to treatment failure
time to progressive disease
progression-free survival
overall survival
To characterize the quantitative and qualitative toxicities of pemetrexed plus gemcitabine in this patient population.

Estimated Enrollment:	48
Study Start Date:	February 2003
Estimated Study Completion Date:	February 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Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating pemetrexed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 1-2 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: NCT00061464

Locations


United States, Florida
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
	Miami, Florida, United States

United States, Illinois
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
	Chicago, Illinois, United States

United States, Louisiana
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
	Shreveport, Louisiana, United States

United States, South Carolina
	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
	Columbia, South Carolina, 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

Study ID Numbers:	7211, H3E-US-JMFX
First Received:	May 28, 2003
Last Updated:	January 24, 2007
ClinicalTrials.gov Identifier:	NCT00061464
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Folic Acid

Pemetrexed

Thoracic Neoplasms

Non-small cell lung cancer

Respiratory Tract Diseases

Lung Neoplasms

Lung Diseases

Gemcitabine

Carcinoma, Non-Small-Cell Lung

Neoplasms, Glandular and Epithelial

Carcinoma

Additional relevant MeSH terms:

Antimetabolites

Respiratory Tract Neoplasms

Anti-Infective Agents

Neoplasms by Histologic Type

Antimetabolites, Antineoplastic

Immunologic Factors

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Physiological Effects of Drugs

Enzyme Inhibitors

Folic Acid Antagonists

Immunosuppressive Agents

Antiviral Agents

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Radiation-Sensitizing Agents

Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2008

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00061464