Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00103337
Status:
COMPLETED
Last Update Posted:
2013-02-28
First Post:
2005-02-07
Brief Title:
Cilengitide in Treating Patients With Metastatic Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Evaluation of EMD121974 NSC 707544 Cilengitide in Asymptomatic Patients With Metastatic Androgen Independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2013-02
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 randomized phase II trial is studying how well cilengitide works in treating patients with metastatic prostate cancer Cilengitide may stop the growth of prostate cancer by blocking blood flow to the tumor
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the efficacy as measured by the rates of clinical progression at six-months of two dose levels of EMD121974 in patients with asymptomatic metastatic androgen-independent prostate cancer
SECONDARY OBJECTIVES
I To evaluate the safety of the two dose levels of EMD121974 in patients with metastatic androgen-independent prostate cancer
II To assess the objective response rate of two dose levels of EMD121974 in patients with metastatic androgen-independent prostate cancer and bidimensionally measurable disease
III To assess the rate of 50 or greater decline in the level of Prostate Specific Antigen
TERTIARY OBJECTIVES
I To determine the effects of integrin αvβ3 and αvβ5 inhibition on total circulating tumor cells and endothelial cells isolated from peripheral blood and bone marrow aspirates from patients with metastatic androgen-independent prostate cancer
II To study the genotypicphenotypic variances in circulating tumor cells in patients with metastatic androgen-independent prostate cancer before and after EMD121974 treatment
III To develop a genetic profile by cDNA microarray analysis of circulating tumor cells isolated from patients with metastatic androgen-independent prostate cancer before and after integrin αvβ3 and αvβ5 inhibition
IV Determine the effects of integrin αvβ3 and αvβ5 inhibition on systemic bone remodeling markers in patients with metastatic androgen-independent prostate cancer
OUTLINE This is an open-label randomized multicenter study Patients are stratified according to prior bisphosphonate use yes vs no Patients are randomized to 1 of 2 doses of cilengitide
ARM I Patients receive lower dose cilengitide IV over 1 hour twice a week for 6 weeks
AMR II Patients receive higher dose cilengitide IV over 1 hour twice a week for 6 weeks
In both arms treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity After 2 courses patients undergo response assessment Patients achieving a complete response CR receive at least 3 additional courses beyond documentation of CR Patients with partial response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity Patients with a mixed response may continue treatment at the discretion of the investigator
Patients are followed for survival
I To evaluate the efficacy as measured by the rates of clinical progression at six-months of two dose levels of EMD121974 in patients with asymptomatic metastatic androgen-independent prostate cancer
SECONDARY OBJECTIVES
I To evaluate the safety of the two dose levels of EMD121974 in patients with metastatic androgen-independent prostate cancer
II To assess the objective response rate of two dose levels of EMD121974 in patients with metastatic androgen-independent prostate cancer and bidimensionally measurable disease
III To assess the rate of 50 or greater decline in the level of Prostate Specific Antigen
TERTIARY OBJECTIVES
I To determine the effects of integrin αvβ3 and αvβ5 inhibition on total circulating tumor cells and endothelial cells isolated from peripheral blood and bone marrow aspirates from patients with metastatic androgen-independent prostate cancer
II To study the genotypicphenotypic variances in circulating tumor cells in patients with metastatic androgen-independent prostate cancer before and after EMD121974 treatment
III To develop a genetic profile by cDNA microarray analysis of circulating tumor cells isolated from patients with metastatic androgen-independent prostate cancer before and after integrin αvβ3 and αvβ5 inhibition
IV Determine the effects of integrin αvβ3 and αvβ5 inhibition on systemic bone remodeling markers in patients with metastatic androgen-independent prostate cancer
OUTLINE This is an open-label randomized multicenter study Patients are stratified according to prior bisphosphonate use yes vs no Patients are randomized to 1 of 2 doses of cilengitide
ARM I Patients receive lower dose cilengitide IV over 1 hour twice a week for 6 weeks
AMR II Patients receive higher dose cilengitide IV over 1 hour twice a week for 6 weeks
In both arms treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity After 2 courses patients undergo response assessment Patients achieving a complete response CR receive at least 3 additional courses beyond documentation of CR Patients with partial response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity Patients with a mixed response may continue treatment at the discretion of the investigator
Patients are followed for survival
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 |
|---|---|---|---|
| UMCC 2004030 | None | None | None |
| N01CM62202 | NIH | None | httpsreporternihgovquickSearchN01CM62202 |