Molecular And Genetic Changes In Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) Following Neoadjuvant Chemotherapy With Vinorelbine And Gemcitabine - Phase II Study
- Determine the frequency of expression of epithelial markers CK19, CK20, MUC1, and MUC5
(by reverse transcriptase-polymerase chain reaction) in lymph node tissue and blood
samples of patients with resectable stage IB-III non-small cell lung cancer treated
with neoadjuvant vinorelbine and gemcitabine followed by surgery.
- Determine the expression of the multidrug resistance-associated protein gene before and
after treatment with this regimen in these patients.
- Determine the global expression profile of genes (by microarray technology) in tumor
tissue of patients treated with this regimen.
- Determine the frequency of loss of heterozygosity at several loci on chromosomes 3p,
9p, and 11p before and after treatment with this regimen in these patients.
- Determine the percent positivity of cells that stain for MCM2 and CDC6 (prereplicative
complex) by immunohistochemistry before and after treatment with this regimen in these
- Determine the feasibility of this regimen in these patients.
- Determine the pathological response rates in patients treated with this regimen.
- Determine the side effects of this regimen in these patients.
- Determine the disease-free and overall survival of patients treated with this regimen.
- Determine the autologous immune response in patients treated with this regimen.
OUTLINE: Patients receive vinorelbine IV over 6-10 minutes and gemcitabine IV over 30
minutes on days 1, 8, 22, and 29 in the absence of disease progression or unacceptable
Patients with no disease progression by scans or bronchoscopy undergo surgical resection
between days 57-70 (weeks 8-10).
Loss of heterozygosity (LOH) at loci on chromosomes 3p, 9p, and 11p is assessed in blood
specimens, tumor tissue, and noncancerous tissue before and after chemotherapy. Specimens
are also examined for molecular markers of occult metastasis using reverse
transcriptase-polymerase chain reaction. Multidrug resistance-associated protein gene
expression is also determined using microarray technology.
Patients are followed every 3 months for 2 years, every 6 months for 5 years, and then
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
Intervention Model: Single Group Assignment, Primary Purpose: Treatment
Nithya Ramnath, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|