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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00061464

First Posted: May 29, 2003

Last Update Posted: January 26, 2007

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Eli Lilly and Company

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 2


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

Genetics Home Reference related topics: 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 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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


ClinicalTrials.gov Identifier:	NCT00061464 History of Changes
Other Study ID Numbers:	7211 H3E-US-JMFX
First Submitted:	May 28, 2003
First Posted:	May 29, 2003
Last Update Posted:	January 26, 2007
Last Verified:	January 2007

Additional relevant MeSH terms:


Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Gemcitabine Pemetrexed	Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors

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