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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.

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00042679
First received: August 2, 2002
Last updated: July 18, 2006
Last verified: July 2006
  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 2

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.

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Study Start Date: June 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042679

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
Sponsors and Collaborators
Eli Lilly and Company
  More Information

No publications provided

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

Keywords provided by Eli Lilly and Company:
Non-Small-Cell Lung Cancer
Adenocarcinoma
Carcinoma Squamous
Adult Lung Cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carboplatin
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014