Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00410904
Status:
COMPLETED
Last Update Posted:
2018-04-13
First Post:
2006-12-11
Brief Title:
AZD2171 and Pemetrexed Disodium in Treating Patients With Relapsed Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase 2 Study of AZD2171 NSC 732208 in Combination With Pemetrexed in Relapsed Non-Small Cell Lung Cancer NOS 10029514
Status:
COMPLETED
Status Verified Date:
2018-03
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:
This phase II trial is studying how well giving AZD2171 together with pemetrexed disodium works in treating patients with relapsed non-small cell lung cancer AZD2171 and pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth AZD2171 may also stop the growth of tumor cells by blocking blood flow to the tumor Giving AZD2171 together with pemetrexed disodium may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Evaluate the response rate in patients with relapsed non-small cell lung cancer treated with AZD2171 and pemetrexed disodium
SECONDARY OBJECTIVES
I Assess the progression-free and overall survival of patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to prior bevacizumab treatment yes vs no
Patients receive oral AZD2171 once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses Patients also receive pemetrexed disodium IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Note The first course is 4 weeks in duration all subsequent courses are 3 weeks in duration
After completion of study treatment patients are followed at 4 weeks and then periodically thereafter
I Evaluate the response rate in patients with relapsed non-small cell lung cancer treated with AZD2171 and pemetrexed disodium
SECONDARY OBJECTIVES
I Assess the progression-free and overall survival of patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to prior bevacizumab treatment yes vs no
Patients receive oral AZD2171 once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses Patients also receive pemetrexed disodium IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Note The first course is 4 weeks in duration all subsequent courses are 3 weeks in duration
After completion of study treatment patients are followed at 4 weeks and then periodically thereafter
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 |
|---|---|---|---|
| U01CA062487 | NIH | CTEP | httpsreporternihgovquickSearchU01CA062487 |
| NCI-2009-00165 | REGISTRY | None | None |
| CDR0000517316 | None | None | None |
| 2006-042 | OTHER | None | None |
| 7389 | OTHER | None | None |
| P30CA022453 | NIH | None | None |