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| Sponsor: | Eli Lilly and Company |
|---|---|
| Information provided by: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00042679 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Non-Small-Cell Lung Pulmonary Neoplasms Neoplasms, Lung |
Drug: Gemcitabine Drug: Carboplatin Drug: LY900003 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 Start Date: | June 2002 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Bakersfield, California, United States | |
| Berkeley, California, United States | |
| Torrance, California, United States | |
| United States, Florida | |
| Miami Beach, Florida, United States | |
| United States, Illinois | |
| Chicago, Illinois, United States | |
| Park Ridge, Illinois, United States | |
| United States, Maryland | |
| Baltimore, Maryland, United States | |
| United States, Tennessee | |
| Chattanooga, Tennessee, United States | |
| United States, Texas | |
| Lubbock, Texas, United States | |
| United States, Virginia | |
| Charlottesville, Virginia, United States | |
| United States, Wisconsin | |
| Milwaukee, Wisconsin, United States | |
More Information
| ClinicalTrials.gov Identifier: | NCT00042679 History of Changes |
| Other Study ID Numbers: | 6429, H7X-MC-JVAB |
| Study First Received: | August 2, 2002 |
| Last Updated: | July 18, 2006 |
| Health Authority: | United States: Food and Drug Administration |
|
Non-Small-Cell Lung Cancer Adenocarcinoma Carcinoma Squamous Adult Lung Cancer |
|
Neoplasms Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Gemcitabine |
Carboplatin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
