A Trial of Carboplatin and Gemcitabine Versus Gemcitabine Alone in Patients With Non-Small-Cell Lung Cancer

November 10, 2007 updated by: Eli Lilly and Company

A Randomized Phase III Trial of Paraplatin (Carboplatin) + Gemzar Versus Gemzar Alone in Patients With Advanced Non-Small Cell Lung Cancer

To determine and compare the median survival produced by combined Gemcitabine plus Paraplatin versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

242

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75204
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologic or cytologic new diagnosis of NSCLC, Stage IIIB with a cytologically positive pleural or pericardial effusion or Stage IV.
  • No prior chemotherapy, including adjuvant or neoadjuvant therapy, for the treatment of NSCLC.
  • ECOG Performance Status of 2 .
  • Patients must be at least 3 weeks since major surgery. Patients must be at least 1 week since surgery, such as mediastinoscopy, pleuroscopy, or thoracostomy.
  • Patients must have measurable disease, defined as lesions that can be accurately measured in at least 1 dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than 10 mm with spiral CT scan.

Exclusion Criteria:

  • Any prior radiation therapy to the thoracic area.
  • Active and ongoing systemic infection.
  • Prior radiation to greater than 25% of the bone marrow.
  • ECOG PS other than 2
  • Patients with a known hypersensitivity to gemcitabine and carboplatin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To determine and compare the median survival produced by combined Gemcitabine plus Paraplatin versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2.

Secondary Outcome Measures

Outcome Measure
To determine and compare the 1-year survival produced by combined Paraplatin (carboplatin) + Gemcitabine versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2
To determine the safety of combined Gemcitabine plus Paraplatin versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2
To compare the response rate between treatment groups
To compare the changes in QOL between treatment groups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

November 14, 2007

Last Update Submitted That Met QC Criteria

November 10, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9297
  • B9E-US-S358

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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