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.
18 Years
N/A
Both
Carcinoma, Non-Small-Cell Lung, Pulmonary Neoplasms, Neoplasms, Lung
Trial Information
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.
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
6429
NCT ID:
NCT00042679
Start Date:
June 2002
Completion Date:
Related Keywords:
- Carcinoma, Non-Small-Cell Lung
- Pulmonary Neoplasms
- Neoplasms, Lung
- Non-Small-Cell Lung Cancer
- Adenocarcinoma
- Carcinoma Squamous
- Adult Lung Cancer
- Neoplasms
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Nashville, Tennessee 37203-1632 | |
| Austin, Texas 78705 | |
| McLean, Virginia 22101 | |
| Baltimore, Maryland 21287 | |
| Milwaukee, Wisconsin |
