Back to resultsA 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.
Primary Purpose
Carcinoma, Non-Small-Cell Lung, Pulmonary Neoplasms, Neoplasms, Lung
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gemcitabine
Carboplatin
LY900003
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Non-Small-Cell Lung Cancer, Adenocarcinoma, Carcinoma Squamous, Adult Lung Cancer
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00042679
Brief Title
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
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung, Pulmonary Neoplasms, Neoplasms, Lung
Keywords
Non-Small-Cell Lung Cancer, Adenocarcinoma, Carcinoma Squamous, Adult Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Type
Drug
Intervention Name(s)
LY900003
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
City
Bakersfield
State/Province
California
Country
United States
City
Berkeley
State/Province
California
Country
United States
City
Torrance
State/Province
California
Country
United States
City
Miami Beach
State/Province
Florida
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Park Ridge
State/Province
Illinois
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Chattanooga
State/Province
Tennessee
Country
United States
City
Lubbock
State/Province
Texas
Country
United States
City
Charlottesville
State/Province
Virginia
Country
United States
City
Milwaukee
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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.
We'll reach out to this number within 24 hrs