Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-28 @ 9:40 PM
Study NCT ID:
NCT00410904
Status:
COMPLETED
Last Update Posted:
2018-04-13
First Post:
2006-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
AZD2171 and Pemetrexed Disodium in Treating Patients With Relapsed Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2009-00165 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CDR0000517316 | None | None | View | |
| 2006-042 | OTHER | Wayne State University/Karmanos Cancer Institute | View | |
| 7389 | OTHER | CTEP | View | |
| P30CA022453 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01CA062487 | NIH | None | https://reporter.nih.gov/quic… | View |