Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057798
Status:
COMPLETED
Last Update Posted:
2011-03-08
First Post:
2003-04-07
Brief Title:
Genetic Changes in Patients With Non-Small Cell Lung Cancer Who Are Receiving Vinorelbine and Gemcitabine Before Surgery
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
OBJECTIVES
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RPCI-RP-00-01 | None | None | None |