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

Tracking Information

First Received Date ^ICMJE

May 28, 2003

Last Updated Date

January 24, 2007

Start Date ^ICMJE

February 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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).

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00061464 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

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.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Carcinoma, Non-Small-Cell Lung

Intervention ^ICMJE

Drug: pemetrexed
Drug: gemcitabine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00061464

Responsible Party

Study ID Numbers ^ICMJE

7211, H3E-US-JMFX

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

Eli Lilly and Company

Verification Date

January 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP