Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00103051
Status:
COMPLETED
Last Update Posted:
2012-07-16
First Post:
2005-02-07
Brief Title:
Gemcitabine Cisplatin and Gefitinib in Treating Patients Who Are Undergoing Surgery for Stage III Non-Small Cell Lung Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Phase II Study With Gefitinib Sequentially Following GemcitabineCisplatin as Induction Regimen for Patients With Stage IIIA N2 NSCLC
Status:
COMPLETED
Status Verified Date:
2012-07
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 Drugs used in chemotherapy such as gemcitabine and cisplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Giving gemcitabine and cisplatin together with gefitinib before surgery may shrink the tumor so it can be removed
PURPOSE This phase II trial is studying how well giving gemcitabine and cisplatin together with gefitinib works in treating patients who are undergoing surgery for stage III non-small cell lung cancer
PURPOSE This phase II trial is studying how well giving gemcitabine and cisplatin together with gefitinib works in treating patients who are undergoing surgery for stage III non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Determine the therapeutic activity of neoadjuvant induction therapy comprising gemcitabine cisplatin and gefitinib in patients with stage IIIA non-small cell lung cancer undergoing surgery
Secondary
Determine the safety profile of this regimen in these patients
Determine the stage downsizing and complete resectability rate in patients with no progressive disease who undergo surgery after treatment with this regimen
OUTLINE This is an open-label nonrandomized multicenter study
Patients receive induction therapy comprising gemcitabine IV over 30 minutes on days 1 8 22 29 43 and 50 cisplatin IV over 3-6 hours on days 2 23 and 44 and oral gefitinib once daily on days 51-79 Treatment continues in the absence of disease progression or unacceptable toxicity Within 2-7 days after completion of induction therapy patients with no progressive disease undergo tumor resection
After completion of study treatment patients are followed at least every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 55 patients will be accrued for this study
Primary
Determine the therapeutic activity of neoadjuvant induction therapy comprising gemcitabine cisplatin and gefitinib in patients with stage IIIA non-small cell lung cancer undergoing surgery
Secondary
Determine the safety profile of this regimen in these patients
Determine the stage downsizing and complete resectability rate in patients with no progressive disease who undergo surgery after treatment with this regimen
OUTLINE This is an open-label nonrandomized multicenter study
Patients receive induction therapy comprising gemcitabine IV over 30 minutes on days 1 8 22 29 43 and 50 cisplatin IV over 3-6 hours on days 2 23 and 44 and oral gefitinib once daily on days 51-79 Treatment continues in the absence of disease progression or unacceptable toxicity Within 2-7 days after completion of induction therapy patients with no progressive disease undergo tumor resection
After completion of study treatment patients are followed at least every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 55 patients will be accrued for this study
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 |
|---|---|---|---|
| 2004-001332-23 | EUDRACT_NUMBER | None | None |
| EORTC-08013 | None | None | None |