Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00275028
Status:
COMPLETED
Last Update Posted:
2015-11-09
First Post:
2006-01-10
Brief Title:
AZD2171 in Treating Patients With Recurrent Ovarian Peritoneal or Fallopian Tube Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 2 Study of AZD2171 in Patients With Recurrent Ovarian Primary Peritoneal Serous or Fallopian Tube Cancer
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 recurrent ovarian peritoneal or fallopian tube cancer AZD2171 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
Detailed Description:
PRIMARY OBJECTIVES
I To determine the efficacy of AZD2171 in platinum sensitive and platinum insensitive disease based on either RECIST criteria for patients with measurable cancer radiographically or clinical response benefit modified Gynecologic Cancer Intergroup GCIG CA-125 response or stable disease for at least 16 weeks
SECONDARY OBJECTIVES
I To assess progression-free survival II To assess modified GCIG CA-125 response rate III To assess duration of modified GCIG CA-125 response IV To assess the safety of the recommended phase 2 dose of AZD2171 in this asymptomatic patient population
V To explore the pharmacodynamic effects of AZD2171 by correlating clinical outcomes with an angiogenic profile derived from serial assessments of soluble VEGFR2 circulating endothelial cell levels and VEGFR phosphorylation in circulating endothelial cells
VI To explore pharmacogenetic differences in kdrflk-1 HIF1alpha p53 and endothelial nitric oxide synthase eNOS in PBMCs from subjects who consent separately for pharmacogenetic studies
VII To determine whether oncogenic mutations predict response to AZD2171
OUTLINE This is a multicenter study Patients are stratified according to disease sensitivity platinum-sensitive disease vs platinum-insensitive disease
Patients receive oral AZD2171 once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for up to 2 years
PROJECTED ACCRUAL A total of 71 patients will be accrued for this study
I To determine the efficacy of AZD2171 in platinum sensitive and platinum insensitive disease based on either RECIST criteria for patients with measurable cancer radiographically or clinical response benefit modified Gynecologic Cancer Intergroup GCIG CA-125 response or stable disease for at least 16 weeks
SECONDARY OBJECTIVES
I To assess progression-free survival II To assess modified GCIG CA-125 response rate III To assess duration of modified GCIG CA-125 response IV To assess the safety of the recommended phase 2 dose of AZD2171 in this asymptomatic patient population
V To explore the pharmacodynamic effects of AZD2171 by correlating clinical outcomes with an angiogenic profile derived from serial assessments of soluble VEGFR2 circulating endothelial cell levels and VEGFR phosphorylation in circulating endothelial cells
VI To explore pharmacogenetic differences in kdrflk-1 HIF1alpha p53 and endothelial nitric oxide synthase eNOS in PBMCs from subjects who consent separately for pharmacogenetic studies
VII To determine whether oncogenic mutations predict response to AZD2171
OUTLINE This is a multicenter study Patients are stratified according to disease sensitivity platinum-sensitive disease vs platinum-insensitive disease
Patients receive oral AZD2171 once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for up to 2 years
PROJECTED ACCRUAL A total of 71 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 |
|---|---|---|---|
| U01CA062490 | NIH | Dana-Farber Cancer Institute | httpsreporternihgovquickSearchU01CA062490 |
| 05-170 | OTHER | None | None |