Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459121
Status:
TERMINATED
Last Update Posted:
2019-03-26
First Post:
2007-04-09
Brief Title:
Vandetanib Carboplatin and Paclitaxel in Treating Patients With Stage I Stage II or Stage III Non-Small Cell Lung Cancer That Can Be Removed by Surgery
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
Assessment of Feasibility and Safety of the Addition of ZD6474 Zactima to Carboplatin and Paclitaxel Administered Neo-Adjuvantly in Stage IB II and T3 N1 Non-Small Cell Lung Cancer NSCLC
Status:
TERMINATED
Status Verified Date:
2013-02
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 Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor Drugs used in chemotherapy such as carboplatin and paclitaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving vandetanib together with chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed
PURPOSE This phase II trial is studying how well giving vandetanib together with carboplatin and paclitaxel works in treating patients with stage I stage II or stage III non-small cell lung cancer that can be removed by surgery
PURPOSE This phase II trial is studying how well giving vandetanib together with carboplatin and paclitaxel works in treating patients with stage I stage II or stage III non-small cell lung cancer that can be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Determine the feasibility of neoadjuvant vandetanib in combination with carboplatin and paclitaxel in patients with resectable stage IB II or IIIA non-small cell lung cancer
Secondary
Assess the 30-day postoperative mortality rate in these patients
Assess the toxicity of this regimen in these patients
Determine the percentage of patients who complete all planned courses of therapy
Assess the clinical response rate in patients treated with this regimen
Assess the pathologic complete response rate in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive oral vandetanib once daily on days 1-21 Patients also receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 Treatment repeats every 3 weeks for up to 3 courses
Patients undergo surgery at least 3 weeks after the last course of chemotherapy
PROJECTED ACCRUAL A total of 15 patients will be accrued for this study
Primary
Determine the feasibility of neoadjuvant vandetanib in combination with carboplatin and paclitaxel in patients with resectable stage IB II or IIIA non-small cell lung cancer
Secondary
Assess the 30-day postoperative mortality rate in these patients
Assess the toxicity of this regimen in these patients
Determine the percentage of patients who complete all planned courses of therapy
Assess the clinical response rate in patients treated with this regimen
Assess the pathologic complete response rate in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive oral vandetanib once daily on days 1-21 Patients also receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 Treatment repeats every 3 weeks for up to 3 courses
Patients undergo surgery at least 3 weeks after the last course of chemotherapy
PROJECTED ACCRUAL A total of 15 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 |
|---|---|---|---|
| ZENECA-IRUSZACT0029 | Other Identifier | Wayne State University - Human Investigation Committee | httpsreporternihgovquickSearchP30CA022453 |
| P30CA022453 | NIH | None | None |
| WSU-2006-122 | OTHER | None | None |
| WSU-011807MP2F | OTHER | None | None |
| WSU-0612004427 | OTHER | None | None |