Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121238
Status:
COMPLETED
Last Update Posted:
2016-04-28
First Post:
2005-07-19
Brief Title:
Cilengitide in Treating Patients With Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Evaluation of EMD 121974 NSC 707544 Cilengitide in Patients With Non-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 phase II trial is studying how well cilengitide works in treating patients with prostate cancer Cilengitide may stop the growth of prostate cancer by blocking blood flow to the tumor
Detailed Description:
PRIMARY OBJECTIVES
I To assess the rate of Prostate Specific Antigen response associated with EMD121974 therapy in patients with non-metastatic androgen-independent prostate cancer
SECONDARY OBJECTIVES
I To evaluate the safety of EMD121974 in patients with non-metastatic androgen-independent prostate cancer
II To assess the change in the slope of Prostate Specific Antigen associated with EMD121974 in patients with non-metastatic androgen-independent prostate cancer
III To assess response duration time to progression and survival
TERTIARY OBJECTIVES
I To determine the effects of integrin αvβ3 and αvβ5 inhibition on total circulating tumor and endothelial cells isolated from peripheral blood and bone marrow aspirates from patients with non-metastatic androgen-independent prostate cancer
II To study the genotypicphenotypic variances in circulating tumor cells in patients with non-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 non-metastatic androgen-independent prostate cancer before and after integrin αvβ3 and αvβ5 inhibition
OUTLINE This is an open-label multicenter study
Patients receive cilengitide IV over 1 hour on days 1 4 8 11 15 18 22 and 25 Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity After 3 courses patients undergo evaluation Patients achieving a complete prostate-specific antigen PSA response ie PSA 02 ngmL receive 2-3 additional courses of therapy Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity Patients demonstrating disease progression by CT scan MRI or bone scan are removed from the study
I To assess the rate of Prostate Specific Antigen response associated with EMD121974 therapy in patients with non-metastatic androgen-independent prostate cancer
SECONDARY OBJECTIVES
I To evaluate the safety of EMD121974 in patients with non-metastatic androgen-independent prostate cancer
II To assess the change in the slope of Prostate Specific Antigen associated with EMD121974 in patients with non-metastatic androgen-independent prostate cancer
III To assess response duration time to progression and survival
TERTIARY OBJECTIVES
I To determine the effects of integrin αvβ3 and αvβ5 inhibition on total circulating tumor and endothelial cells isolated from peripheral blood and bone marrow aspirates from patients with non-metastatic androgen-independent prostate cancer
II To study the genotypicphenotypic variances in circulating tumor cells in patients with non-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 non-metastatic androgen-independent prostate cancer before and after integrin αvβ3 and αvβ5 inhibition
OUTLINE This is an open-label multicenter study
Patients receive cilengitide IV over 1 hour on days 1 4 8 11 15 18 22 and 25 Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity After 3 courses patients undergo evaluation Patients achieving a complete prostate-specific antigen PSA response ie PSA 02 ngmL receive 2-3 additional courses of therapy Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity Patients demonstrating disease progression by CT scan MRI or bone scan are removed from the 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 |
|---|---|---|---|
| CDR0000438708 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM62206 |
| 2004-045 | OTHER | None | None |
| N01CM62206 | NIH | None | None |