Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00436956
Status:
COMPLETED
Last Update Posted:
2018-10-09
First Post:
2007-02-15
Brief Title:
AZD2171 to Treat Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase II Study of AZD2171 in Metastatic Androgen Independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2018-10
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:
Background
AZD2171 Cediranib is an experimental drug that inhibits formation of new blood vessels
Tumors need new blood vessels to grow Preventing the growth of new blood vessels with AZD2171 may inhibit tumor growth
Objectives
-To determine the effectiveness and side effects of AZD2171 in patients with prostate cancer that has metastasized spread beyond the primary site
Eligibility
Males 18 years of age and older with androgen-independent prostate cancer that has metastasized
Patients must have received prior treatment with docetaxel
Design
Patients take one AZD2171 by mouth every day in 28-day treatment cycles and undergo the following procedures
1- to 2-day hospitalization at the start of the study for biopsies and blood measurements to determine the level of AZD2171 in the bloodstream Blood is drawn immediately before the first dose and 025 hr 05 hr 1 hr 2 hr 4 hr 6 hr 8 hr 12 hr 24 hr and 48 hours after the dose is taken
Blood tests before starting treatment and then monthly to determine the level of vascular endothelial growth factor receptor VEGFR a protein involved in blood vessel formation
Magnetic resonance imaging MRI scans once a month to evaluate blood flow
Tumor biopsies optional both before and after the second and sixth treatment cycles
Clinic visits every 4 weeks including various routine and research blood tests urine test and electrocardiogram
Computed tomography CT scan of the chest abdomen and pelvis every 8 weeks
Bone scan every 8 weeks
Patients record all doses of AZD2171 taken or missed in a pill diary They record their blood pressure at least once daily in a blood pressure diary
Treatment may continue as long as the patient tolerates the AZD2171 and the cancer does not worsen
AZD2171 Cediranib is an experimental drug that inhibits formation of new blood vessels
Tumors need new blood vessels to grow Preventing the growth of new blood vessels with AZD2171 may inhibit tumor growth
Objectives
-To determine the effectiveness and side effects of AZD2171 in patients with prostate cancer that has metastasized spread beyond the primary site
Eligibility
Males 18 years of age and older with androgen-independent prostate cancer that has metastasized
Patients must have received prior treatment with docetaxel
Design
Patients take one AZD2171 by mouth every day in 28-day treatment cycles and undergo the following procedures
1- to 2-day hospitalization at the start of the study for biopsies and blood measurements to determine the level of AZD2171 in the bloodstream Blood is drawn immediately before the first dose and 025 hr 05 hr 1 hr 2 hr 4 hr 6 hr 8 hr 12 hr 24 hr and 48 hours after the dose is taken
Blood tests before starting treatment and then monthly to determine the level of vascular endothelial growth factor receptor VEGFR a protein involved in blood vessel formation
Magnetic resonance imaging MRI scans once a month to evaluate blood flow
Tumor biopsies optional both before and after the second and sixth treatment cycles
Clinic visits every 4 weeks including various routine and research blood tests urine test and electrocardiogram
Computed tomography CT scan of the chest abdomen and pelvis every 8 weeks
Bone scan every 8 weeks
Patients record all doses of AZD2171 taken or missed in a pill diary They record their blood pressure at least once daily in a blood pressure diary
Treatment may continue as long as the patient tolerates the AZD2171 and the cancer does not worsen
Detailed Description:
Background
AZD2171 Cediranib is an oral potent inhibitor of receptor tyrosine kinases which impact vascular endothelial growth factor-A VEGF
VEGF appears important in blood vessel formation and disease progression in prostate cancer
No known effective therapy in patients with progressive androgen-independent prostate cancer after treatment with docetaxel
Objectives
Primary objective of this study is to determine if AZD2171 is associated with a 30 6 month probability of progression free survival in patients with metastatic androgen independent prostate cancer AIPC as determined by clinical and radiographic criteria
Secondary objective of this study will be demonstration of biologic effect by the drug in the patient and on the tumor when possible Correlative studies will be conducted on serially obtained tissue biopsies and white blood cell collections
Laboratory correlates will include elucidation of activation of components of the VEGFR2 and angiogenesis pathways and evaluation of endothelial cell adhesion molecules released by damaged cells using enzyme-linked immunosorbent assay ELISA pharmacogenetic analysis of kinase insert domain receptor KDR variants and single nucleotide polymorphisms and pharmacokinetic characterization of AZD2171 activity
Eligibility
Metastatic progressive androgen-independent prostate cancer
Prior treatment with docetaxel
May not have corrected QT interval QTc greater than 470 msec or greater than 1 proteinuria on 2 consecutive dipsticks no less than 1 week apart
Design
Phase II trial with a two stage design 12 patients enrolled in first cohort if 2 or more are progression free at 6 months than enroll up to 35 evaluable patients The ceiling will be set at 37 to allow for inevaluable patients
Starting dose 20 mg QD every day for all patients
Once two stage design is complete then prednisone 10 mg once per day will be given in combination with AZD2171 The total number of patients will be 23 for this portion of the protocol
AZD2171 Cediranib is an oral potent inhibitor of receptor tyrosine kinases which impact vascular endothelial growth factor-A VEGF
VEGF appears important in blood vessel formation and disease progression in prostate cancer
No known effective therapy in patients with progressive androgen-independent prostate cancer after treatment with docetaxel
Objectives
Primary objective of this study is to determine if AZD2171 is associated with a 30 6 month probability of progression free survival in patients with metastatic androgen independent prostate cancer AIPC as determined by clinical and radiographic criteria
Secondary objective of this study will be demonstration of biologic effect by the drug in the patient and on the tumor when possible Correlative studies will be conducted on serially obtained tissue biopsies and white blood cell collections
Laboratory correlates will include elucidation of activation of components of the VEGFR2 and angiogenesis pathways and evaluation of endothelial cell adhesion molecules released by damaged cells using enzyme-linked immunosorbent assay ELISA pharmacogenetic analysis of kinase insert domain receptor KDR variants and single nucleotide polymorphisms and pharmacokinetic characterization of AZD2171 activity
Eligibility
Metastatic progressive androgen-independent prostate cancer
Prior treatment with docetaxel
May not have corrected QT interval QTc greater than 470 msec or greater than 1 proteinuria on 2 consecutive dipsticks no less than 1 week apart
Design
Phase II trial with a two stage design 12 patients enrolled in first cohort if 2 or more are progression free at 6 months than enroll up to 35 evaluable patients The ceiling will be set at 37 to allow for inevaluable patients
Starting dose 20 mg QD every day for all patients
Once two stage design is complete then prednisone 10 mg once per day will be given in combination with AZD2171 The total number of patients will be 23 for this portion of the protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 07-C-0059 | None | None | None |