Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00509366
Status:
TERMINATED
Last Update Posted:
2014-08-28
First Post:
2007-07-30
Brief Title:
Study Using a Genomic Predictor of Platinum Resistance to Guide Therapy in Stage IIIBIV Non-Small Cell Lung Cancer
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Phase II Prospective Study Evaluating the Role of Personalized Chemotherapy Regimens for Chemo-Naive Select Stage IIIB and IV Non-Small Cell Lung Cancer NSCLC in Patients Using a Genomic Predictor of Platinum Resistance to Guide Therapy
Status:
TERMINATED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated due to reproducibility issues with genomics prediction model
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TOP0602
Brief Summary:
In this trial subjects with chemo-naive advanced non-small cell lung cancer NSCLC were assigned to chemotherapy using a genomic-based predictor for platinum sensitivity After an amendment dated 1252010 subjects with squamous cell NSCLC sensitive to cisplatin received cisplatingemcitabine and if resistant to cisplatin received docetaxelgemcitabine Subjects with non-squamous cell NSCLC sensitive to cisplatin received cisplatinpemetrexed and if resistant to cisplatin received pemetrexedgemcitabine The primary objective of this trial was to prospectively validate the genomic-based prediction model through separate evaluation of the one-year progression-free survival PFS of the cisplatin-sensitive and cisplatin-resistant cohorts Secondary objectives included assessment of overall time to progressive disease quality of life and evaluation of drug sensitivity patterns of cisplatin and pemetrexed
Detailed Description:
Lung cancer is the leading cause of cancer death in both men and women The majority of patients with lung cancer have non-small cell type NSCLC The current standard of care for treating select stage IIIB and stage IV NSCLC is a doublet chemotherapy regimen such as cisplatin plus gemcitabine carboplatin plus paclitaxel or a platinum agent plus vinorelbine All of these regimens have comparable response rates as first-line therapy In addition the combination of cisplatin plus pemetrexed has recently been approved for non-squamous histology based on results of a large randomized prospective trial in advanced stage NSCLC Alternative doublet therapy for first-line treatment of NSCLC per ASCO and NCCN guidelines also include a non-platinum doublet or single agent therapy
An individual patients response to chemotherapy is the result of complex interactions between the drugs and the patients genetics and environment Using Affymetrix gene expression data with corresponding drug response data for cisplatin from the NCI60 lines panel a gene expression based model predicative of cisplatin-resistant has been developed However reevaluation of the genomics-based prediction model showed that it was irreproducible suggesting inaccurate patient assignments into the two cisplatin cohorts As a result it would be inappropriate to separately analyze outcomes for the different treatment groups Instead information from both cisplatin cohorts will be combined to reflect the overall measure of one-year progression-free survival in this study Secondary outcomes will also reflect the overall measures of median time to disease progression and quality of life
An individual patients response to chemotherapy is the result of complex interactions between the drugs and the patients genetics and environment Using Affymetrix gene expression data with corresponding drug response data for cisplatin from the NCI60 lines panel a gene expression based model predicative of cisplatin-resistant has been developed However reevaluation of the genomics-based prediction model showed that it was irreproducible suggesting inaccurate patient assignments into the two cisplatin cohorts As a result it would be inappropriate to separately analyze outcomes for the different treatment groups Instead information from both cisplatin cohorts will be combined to reflect the overall measure of one-year progression-free survival in this study Secondary outcomes will also reflect the overall measures of median time to disease progression and quality of life
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