Genetic Changes in Patients With Non-Small Cell Lung Cancer Who Are Receiving Vinorelbine and Gemcitabine Before Surgery
|ClinicalTrials.gov Identifier: NCT00057798|
Recruitment Status : Completed
First Posted : April 9, 2003
Last Update Posted : March 8, 2011
RATIONALE: Determination of genetic changes in patients with non-small cell lung cancer may help predict the outcome of treatment. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them before surgery, may shrink the tumor so that it can be removed during surgery.
PURPOSE: Phase II trial to study genetic changes and the effectiveness of combining vinorelbine with gemcitabine before surgery in treating patients who have stage IB, stage II, or stage III non-small cell lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: gemcitabine hydrochloride Drug: vinorelbine ditartrate Genetic: cytogenetic analysis Genetic: loss of heterozygosity analysis Genetic: microarray analysis Procedure: conventional surgery Procedure: neoadjuvant therapy||Phase 2|
- 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 patients.
- 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 toxicity.
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 annually thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Molecular And Genetic Changes In Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) Following Neoadjuvant Chemotherapy With Vinorelbine And Gemcitabine - Phase II Study|
|Study Start Date :||March 2000|
|Actual Primary Completion Date :||May 2003|
|Actual Study Completion Date :||June 2008|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057798
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Study Chair:||Nithya Ramnath, MD||Roswell Park Cancer Institute|