Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00104728
Status:
TERMINATED
Last Update Posted:
2012-10-31
First Post:
2005-03-03
Brief Title:
Neoadjuvant IRESSA As Single Agent PreopTherapy for NSCLC With Molecular Correlates
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Pilot Neoadjuvant Study of ZD1839 IRESSA as Single Agent Preoperative Therapy for Clinical Stage 1A and 1B T1-2N0 II T1-2N1 T3N0 and Selected IIIA T3N1 Non-Small Cell Lung Cancer NSCLC With Molecular Correlates
Status:
TERMINATED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Early Stopping Rule Would not meet interim analysis goal to proceed with enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Giving gefitinib before surgery may shrink the tumor so it can be removed
PURPOSE This phase II trial is studying how well gefitinib works in treating patients who are undergoing surgery for stage I stage II or stage III non-small cell lung cancer
PURPOSE This phase II trial is studying how well gefitinib works in treating patients who are undergoing surgery for stage I stage II or stage III non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Determine the effects of neoadjuvant gefitinib on downstream signaling pathways including Src-Stat3 PI3KAkt ERK activity and Bcl-2 family members in patients with resectable stage I-IIIA non-small cell lung cancer
Determine the effects of this drug on cell cycle and apoptosis within the primary tumor by measuring changes in pre- and post-treatment Ki-67 Mcm2 cleaved caspase-3 and ApoTag in these patients
Secondary
Determine the clinical response rate in patients treated with this drug
Determine the pathological response rate defined as 95 necrosis or fibrosis in the pathological specimen in patients treated with this drug
Determine the metabolic activity of this drug in these patients
Determine the safety tolerability and feasibility of this drug in terms of toxicity and post-treatment resectability in these patients
Correlate plasma and tumor concentrations of this drug with changes in post-treatment molecular markers in these patients
Identify a gene profile that predicts response to this drug in these patients
OUTLINE This is an open-label pilot study
Patients receive oral gefitinib once daily for 4 weeks in the absence of disease progression or unacceptable toxicity
Within 3 days after completion of gefitinib patients undergo restaging evaluation Patients whose disease is still considered resectable proceed to surgery Patients undergo thoracotomy with lobectomy or pneumonectomy OR sleeve resection Patients also undergo mediastinal lymph node dissection After surgical resection treatment with gefitinib may continue off study at the discretion of the principal investigator
After completion of study therapy patients are followed at 30 days every 4 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study within 125 months
Primary
Determine the effects of neoadjuvant gefitinib on downstream signaling pathways including Src-Stat3 PI3KAkt ERK activity and Bcl-2 family members in patients with resectable stage I-IIIA non-small cell lung cancer
Determine the effects of this drug on cell cycle and apoptosis within the primary tumor by measuring changes in pre- and post-treatment Ki-67 Mcm2 cleaved caspase-3 and ApoTag in these patients
Secondary
Determine the clinical response rate in patients treated with this drug
Determine the pathological response rate defined as 95 necrosis or fibrosis in the pathological specimen in patients treated with this drug
Determine the metabolic activity of this drug in these patients
Determine the safety tolerability and feasibility of this drug in terms of toxicity and post-treatment resectability in these patients
Correlate plasma and tumor concentrations of this drug with changes in post-treatment molecular markers in these patients
Identify a gene profile that predicts response to this drug in these patients
OUTLINE This is an open-label pilot study
Patients receive oral gefitinib once daily for 4 weeks in the absence of disease progression or unacceptable toxicity
Within 3 days after completion of gefitinib patients undergo restaging evaluation Patients whose disease is still considered resectable proceed to surgery Patients undergo thoracotomy with lobectomy or pneumonectomy OR sleeve resection Patients also undergo mediastinal lymph node dissection After surgical resection treatment with gefitinib may continue off study at the discretion of the principal investigator
After completion of study therapy patients are followed at 30 days every 4 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study within 125 months
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 |
|---|---|---|---|
| IRUSIRES0256 | OTHER | AstraZeneca | None |