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. - Tabular View

Tracking Information
First Received Date ^ICMJE	August 2, 2002
Last Updated Date	July 18, 2006
Start Date ^ICMJE	June 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00042679 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	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.
Official Title ^ICMJE	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.
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 Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Carcinoma, Non-Small-Cell Lung Pulmonary Neoplasms Neoplasms, Lung
Intervention ^ICMJE	Drug: Gemcitabine Drug: Carboplatin Drug: LY900003
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00042679
Responsible Party
Study ID Numbers ^ICMJE	6429, H7X-MC-JVAB
Study Sponsor ^ICMJE	Eli Lilly and Company
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Eli Lilly and Company
Verification Date	July 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP