Phase II Multidose, Single Arm, Multicenter Clinical Trial of Cisplatin and Gemcitabine in Combination With Recombinant Humanized Anti-p185HER2 Monoclonal Antibody (Herceptin) in Patients Who Have Untreated p185HER2 Overexpressing Advanced Local Stage (Stage IIIb Pleural Effusion Only) and Metastatic (Stage IV) Non-Small Cell Lung Cancer
OBJECTIVES: I. Determine the therapeutic efficacy and toxicity of cisplatin, gemcitabine,
and trastuzumab (Herceptin) in patients with untreated p185-HER2 overexpressing stage IIIB
or IV non-small cell lung cancer. II. Determine the pharmacokinetic interactions among these
drugs in these patients. III. Assess the pharmacodynamics of these drugs in these patients.
OUTLINE: This is a multicenter study. Regimen A: Patients receive gemcitabine IV over 30
minutes followed by cisplatin IV over 2 hours on day 1 and trastuzumab (Herceptin) IV over
90 minutes on day 2. Patients receive trastuzumab IV over 90 minutes followed by gemcitabine
IV over 30 minutes on day 8 and trastuzumab IV over 90 minutes on day 15. Patients proceed
to regimen B on day 22 of regimen A. Regimen B: Patients receive trastuzumab IV over 30-90
minutes, gemcitabine IV over 30 minutes, and cisplatin IV over 2 hours on day 1. Patients
receive trastuzumab IV over 30-90 minutes followed by gemcitabine IV over 30 minutes on day
8 and trastuzumab IV over 30-90 minutes on day 15. Treatment repeats every 21 days for up to
5 courses in the absence of disease progression or unacceptable toxicity. Maintenance: After
completion of 6 courses, patients with stable disease or partial response receive
trastuzumab IV over 30-90 minutes weekly until tumor progression.
PROJECTED ACCRUAL: A total of 20-48 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy of Cisplatin, Gemcitabine, + Trastuzumab in Untreated p185-HER2 Overexpressing Stage IIIB or IV Non-small Cell Lung Cancer
21 days cycles for 6 courses
Roy S. Herbst, MD, PhD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|