A Prospective, Randomized, Open-Label, Phase III Trial of Chemotherapy With Carboplatin And Paclitaxel, Versus Carboplatin And Paclitaxel In Combination With ISIS-3521, An Antisense Inhibitor Of Protein Kinase C Alpha In Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer
OBJECTIVES: I. Compare the overall survival of patients with stage IIIB or IV non-small cell
lung cancer treated with carboplatin and paclitaxel with vs without ISIS 3521. II. Compare
the time to tumor progression and time to treatment failure in patients treated with these
regimens. III. Compare the overall (complete plus partial) response rate in patients with
measurable disease treated with these regimens. IV. Compare the percentage of patients with
non-measurable, evaluable disease who have a complete response after treatment with these
regimens. V. Compare the duration of response in patients with a complete or partial
response after treatment with these regimens. VI. Compare the safety of these regimens in
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to tumor stage (IIIB vs IV) and prior brain metastases (yes vs no). Patients are
randomized to one of two treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours
and carboplatin IV over 1 hour on day 0. Arm II: Patients receive ISIS 3521 IV continuously
on days 0-14 and paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 3.
Treatment repeats every 21 days in the absence of disease progression or unacceptable
toxicity. Patients with stable or responsive disease receive 6 courses of treatment.
Patients with responsive disease may receive additional courses of treatment. Patients are
followed at 1, 2, 4, and 6 months and then every 3 months thereafter.
PROJECTED ACCRUAL: Approximately 600 patients (300 per treatment arm) will be accrued for
this study within 15 months.
Primary Purpose: Treatment
Jon Holmlund, MD
United States: Federal Government
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|
|ISIS Pharmaceuticals, Inc.||Carlsbad, California 92008|