A Phase 2 Trial of Antisense Nucleotide to PKC-Alpha (LY900003, ISIS 3521) Plus Gemcitabine and Carboplatin in Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer.

July 18, 2006 updated by: Eli Lilly and Company

The purposes of this study are to determine the following:

Whether LY900003 plus gemcitabine and carboplatin can make your tumor smaller or disappear, and for how long.

If treatment with LY900003 plus gemcitabine and carboplatin can help you live longer.

The safety of LY900003 plus gemcitabine and carboplatin and any side effects that might be associated with the combination of these three drugs.

How LY900003 is distributed and broken down by your body when it is given with carboplatin and gemcitabine.

Whether LY900003 affects the way gemcitabine and carboplatin are distributed and broken down by your body.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Definition: The phase 2 study will provide important information regarding effects of LY900003 on safety and efficacy of patients treated with gemcitabine and carboplatin. LY900003 will be given at approximately 2 mg/kg/day for the first 14 days of a 21-day cycle. The dose and schedule for LY900003 administration are based on results of prior studies of LY900003 and are currently being used in other studies of LY900003. Gemcitabine will be administered on Days 1 and 8 at 1250 mg/m2 and carboplatin will be given on Day 1 at AUC 5.

Study Type

Interventional

Phase

Phase 2

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
- California
  - Bakersfield, California, United States
  - Berkeley, California, United States
  - Torrance, California, United States
- Florida
  - Miami Beach, Florida, United States
- Illinois
  - Chicago, Illinois, United States
  - Park Ridge, Illinois, United States
- Maryland
  - Baltimore, Maryland, United States
- Tennessee
  - Chattanooga, Tennessee, United States
- Texas
  - Lubbock, Texas, United States
- Virginia
  - Charlottesville, Virginia, United States
- Wisconsin
  - Milwaukee, Wisconsin, United States

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

Diagnosis of Non-Small-Cell Lung Cancer.
Stage IV or Stage IIIB disease.
ECOG Performance Status of 0 or 1.
Adequate organ function
One unidimensionally measurable lesion.

Exclusion Criteria:

Prior therapy for NSCLC.
Serious concomitant disorders.
Untreated CNS metastases.
Uncontrolled, active infection.
Previous LY900003/ISIS trial participation.

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: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

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

June 1, 2002

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

August 2, 2002

First Submitted That Met QC Criteria

August 5, 2002

First Posted (Estimate)

August 6, 2002

Study Record Updates

Last Update Posted (Estimate)

July 19, 2006

Last Update Submitted That Met QC Criteria

July 18, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

6429 (Other Grant/Funding Number: Tata Memorial Hospital)
H7X-MC-JVAB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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.