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.

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.

Completed

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Adenocarcinoma Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Squamous Cell Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Lung Neoplasms, Squamous Cell Pulmonary Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bakersfield, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gemcitabine

Drug

carboplatin

Drug

LY900003

Drug

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Important dates

Study start: 2002
First posted: Aug 6, 2002
Registry last updated: Jul 19, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed