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.

Phase 2

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung; Pulmonary Neoplasms; Neoplasms, Lung

• Registration Number: NCT00042679
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

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 Timeline

• Study Start: 2002-06
• Study First Submitted: 2002-08-02
• Study First Submitted QC: 2002-08-05
• Study First Posted: 2002-08-06
• Status Verified: 2006-07
• Last Update Submitted: 2006-07-18
• Last Update Posted: 2006-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP