Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) - Tabular View

Tracking Information

First Received Date ^ICMJE

October 13, 2003

Last Updated Date

January 24, 2007

Start Date ^ICMJE

December 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

To find out how often tumors become smaller or disappear in patients with advanced NSCLC treated with gemcitabine followed by pemetrexed once every 14 days. Chemotherapy treatment will be given for up to 12 times or until the cancer disease increases.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00071136 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To measure the effects of chemotherapy treatment on:
time until the cancer becomes less;time to cancer re-appears or becomes larger;length of time there is no increase in the amount of cancer;length of time patients survive;
To measure the side-effects from this chemotherapy as given once every 14 days.

Original Secondary Outcome Measures ^ICMJE

To measure the effects of chemotherapy treatment on:
-time until the cancer becomes less
-time to cancer re-appears or becomes larger
-length of time there is no increase in the amount of cancer
-length of time patients survive
To measure the side-effects from this chemotherapy as given once every 14 days.

Descriptive Information

Brief Title ^ICMJE

Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Official Title ^ICMJE

Phase 1/2 Dose-Escalating Study of Biweekly Alimta and Gemcitabine in Patients With Advanced Cancer

Brief Summary

This is a Phase 2 study of pemetrexed and gemcitabine chemotherapy given once every 14 days to patients with advanced stage non-small cell lung cancer. This treatment is for patients that have not received any prior chemotherapy treatment for lung cancer. The primary goal is to find out if the tumor gets smaller or disappears with this treatment.

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Lung Neoplasms

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

August 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Have a diagnosis of advanced stage non-small cell lung cancer.
Are able to be active at home and/or work.
Have not received chemotherapy for this cancer disease.
Have good organ function (for example, most blood work is normal).
Have completed any prior radiation treatment at least 4 weeks ago.

Exclusion Criteria:

Have been treated with an investigational/research drug within the last month.
Have cancer that has spread to the brain and is causing symptoms.
Have an active infection or other serious medical condition.
Have a second cancer in addition to non-small cell lung cancer.
Can not stop taking aspirin or other anti-inflammatory agents for 5-8 days.

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

NCT00071136

Responsible Party

Study ID Numbers ^ICMJE

7221, H3E-US-JMGC

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