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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.

NCT ID: NCT00042679

Last Updated: 2006-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Carcinoma, Non-Small-Cell Lung Pulmonary Neoplasms Neoplasms, Lung

Keywords

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Non-Small-Cell Lung Cancer Adenocarcinoma Carcinoma Squamous Adult Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Gemcitabine

Intervention Type DRUG

Carboplatin

Intervention Type DRUG

LY900003

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Locations

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Bakersfield, California, United States

Site Status

Berkeley, California, United States

Site Status

Torrance, California, United States

Site Status

Miami Beach, Florida, United States

Site Status

Chicago, Illinois, United States

Site Status

Park Ridge, Illinois, United States

Site Status

Baltimore, Maryland, United States

Site Status

Chattanooga, Tennessee, United States

Site Status

Lubbock, Texas, United States

Site Status

Charlottesville, Virginia, United States

Site Status

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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H7X-MC-JVAB

Identifier Type: -

Identifier Source: secondary_id

6429

Identifier Type: -

Identifier Source: org_study_id