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

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

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, 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

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 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

No publications provided

Study ID Numbers:	7211, H3E-US-JMFX
Study First Received:	May 28, 2003
Last Updated:	January 24, 2007
ClinicalTrials.gov Identifier:	NCT00061464 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