Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321724
Status:
COMPLETED
Last Update Posted:
2013-01-15
First Post:
2006-05-02
Brief Title:
AZD2171 in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of AZD2171 in RelapsedRefractory B-Cell Chronic Lymphocytic Leukemia Patients
Status:
COMPLETED
Status Verified Date:
2013-01
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 AZD2171 works in treating patients with relapsed or refractory B-cell chronic lymphocytic leukemia AZD2171 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer cells
Detailed Description:
OBJECTIVES
I Evaluate the response rate in patients with relapsed or refractory B-cell chronic lymphocytic leukemia B-CLL treated with AZD2171
II Evaluate the toxicity of AZD2171 in patients with relapsed or refractory B-CLL
III Evaluate the complete response rate progression-free and overall survival distributions and duration of response in patients with relapsed or refractory B-CLL treated with AZD2171
IV Assess vascular endothelial growth factor receptor-2 VEGFR-2 protein and phosphorylation levels in B-CLL cells using pretreatment samples and evaluate the association between Rai stage at study entry and clinical response to AZD2171
V Perform preclinical testing of AZD2171 in the induction of B-CLL cell apoptosiscell death using pretreatment samples and evaluate the ability to downregulate the phosphorylation status of VEGFR-2 of B-CLL cells by comparing in vitro samples with and without AZD2171
VI Study the differences in in vitro levels of B-CLL cell apoptosiscell death and alteration of VEGFR-2 phosphorylation using pretreatment samples with and without AZD2171 and how these differences correlate with clinical outcomes
VII Assess if the clinical responses are associated with changes in bone marrow vascularity
OUTLINE This is a multicenter study
Patients receive oral AZD2171 once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients undergo blood sampling and biopsies at baseline and periodically throughout study for biomarker and correlative studies
After completion of study therapy patients are followed periodically for up to 5 years from study entry
I Evaluate the response rate in patients with relapsed or refractory B-cell chronic lymphocytic leukemia B-CLL treated with AZD2171
II Evaluate the toxicity of AZD2171 in patients with relapsed or refractory B-CLL
III Evaluate the complete response rate progression-free and overall survival distributions and duration of response in patients with relapsed or refractory B-CLL treated with AZD2171
IV Assess vascular endothelial growth factor receptor-2 VEGFR-2 protein and phosphorylation levels in B-CLL cells using pretreatment samples and evaluate the association between Rai stage at study entry and clinical response to AZD2171
V Perform preclinical testing of AZD2171 in the induction of B-CLL cell apoptosiscell death using pretreatment samples and evaluate the ability to downregulate the phosphorylation status of VEGFR-2 of B-CLL cells by comparing in vitro samples with and without AZD2171
VI Study the differences in in vitro levels of B-CLL cell apoptosiscell death and alteration of VEGFR-2 phosphorylation using pretreatment samples with and without AZD2171 and how these differences correlate with clinical outcomes
VII Assess if the clinical responses are associated with changes in bone marrow vascularity
OUTLINE This is a multicenter study
Patients receive oral AZD2171 once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients undergo blood sampling and biopsies at baseline and periodically throughout study for biomarker and correlative studies
After completion of study therapy patients are followed periodically for up to 5 years from study entry
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 |
|---|---|---|---|
| CDR0000467560 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA025224 |
| NCCTG-N048F | None | None | None |
| U10CA025224 | NIH | None | None |