Lung Cancer Clinical Trial
Official title:
Phase II Pilot Trial of Carboplatin, Paclitaxel, and Herceptin in HER2/Neu (+) Advanced NSCLC
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver
tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy
use different ways to stop tumor cells from dividing so they stop growing or die. Combining
monoclonal antibody therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of the monoclonal antibody trastuzumab
plus carboplatin and paclitaxel in treating patients who have advanced non-small cell lung
cancer.
OBJECTIVES: I. Assess the toxicity of monoclonal antibody HER2 with carboplatin and
paclitaxel in patients with HER2 positive non-small cell lung cancer. II. Determine median
time to progression and one year freedom from progression in this patient population. III.
Evaluate one year survival rate and overall objective response rate in this patient
population.
OUTLINE: Patients receive paclitaxel IV over 3 hours immediately followed by carboplatin IV
over 30 minutes immediately followed by monoclonal antibody HER2 IV over 30-90 minutes on
day 1. Patients also receive monoclonal antibody HER2 on days 8 and 15. Treatment is
repeated every 3 weeks for 6 courses. After 6 courses of treatment, patients may receive
monoclonal antibody HER2 weekly for up to 1 year in the absence of disease progression or
unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for
3 years and once a year thereafter until disease progression or death.
PROJECTED ACCRUAL: A total of 22-44 patients will be accrued for this study.
;
Primary Purpose: Treatment
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