Pemetrexed Plus Gemcitabine as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Clinical Trial - Tabular View

Tracking Information

First Received Date ^ICMJE

May 28, 2003

Last Updated Date

April 7, 2008

Start Date ^ICMJE

December 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

To assess the objective tumor response rate of gemcitabine plus pemetrexed in patients with advanced or metastatic non-small-cell lung cancer.

Original Primary Outcome Measures ^ICMJE

To assess the anti-tumor activity of pemetrexed plus gemcitabine for patients with malignant pleural or peritoneal mesothelioma

Change History

Complete list of historical versions of study NCT00061451 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To assess time to objective tumor response for responding patients
To assess duration of response for responding patients
To assess time to treatment failure for patients
To assess progression free survival of patients
To assess time to progressive disease for patients
To assess survival time for patients
To characterize the toxicities of gemcitabine plus pemetrexed in this patient population

Original Secondary Outcome Measures ^ICMJE

- To assess objective tumor response for responding patients
- To assess duration of response for responding patients
- To assess time to treatment failure for patients
- To assess progression free survival of patients
- To assess time to progressive disease for patients
- To assess survival time for patients
- To determine toxicities of pemetrexed in combination with cisplatin or carboplatin in this population

Descriptive Information

Brief Title ^ICMJE

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

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, Uncontrolled, 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

September 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 4 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

NCT00061451

Responsible Party

Study ID Numbers ^ICMJE

7213, H3E-US-JMFY

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

April 2008

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