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.

Completed · Phase 2

Conditions studied: Carcinoma, Non-Small-Cell Lung, Pulmonary Neoplasms, Neoplasms, Lung

In brief

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.

Key facts

Study ID

NCT00042679

Run by

Eli Lilly and Company

Starts

2002-06-01

Last updated by the study team

2006-07-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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