Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148772
Status:
COMPLETED
Last Update Posted:
2011-06-28
First Post:
2005-09-06
Brief Title:
Study of Erlotinib in Patients With Non-Metastatic Prostate Cancer With a Rising Prostate Specific Antigen PSA on Hormone Therapy
Sponsor:
NorthShore University HealthSystem
Organization:
NorthShore University HealthSystem
Study Overview
Official Title:
Phase II Study of Erlotinib in Patients With Non-Metastatic Prostate Cancer With a Rising PSA on Hormone Therapy
Status:
COMPLETED
Status Verified Date:
2005-08
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:
The primary objective of this study is to evaluate the effect of erlotinib on the PSA response rate in patients with non-metastatic prostate cancer and a rising PSA on androgen deprivation therapy
The secondary objectives are to evaluate the effect of erlotinib on the duration of PSA response to evaluate the effect on the time to PSA progression to evaluate the toxicity of erlotinib in this patient population and lastly to correlate the effect of erlotinib with various epidermal growth factor receptor EGFR-related proteins using baseline immunohistochemical IHC studies on tissue blocks and peripheral blood mononuclear cells
The secondary objectives are to evaluate the effect of erlotinib on the duration of PSA response to evaluate the effect on the time to PSA progression to evaluate the toxicity of erlotinib in this patient population and lastly to correlate the effect of erlotinib with various epidermal growth factor receptor EGFR-related proteins using baseline immunohistochemical IHC studies on tissue blocks and peripheral blood mononuclear cells
Detailed Description:
Patients with prostate cancer who are treated with surgery or radiation often develop recurrence of their cancer which is manifest only by a rising PSA Prostate Specific Antigen level Many of these patients are treated with hormone therapy After a fall in the PSA these patients eventually display evidence of tumor progression clearly demonstrated by another rise in PSA level while receiving hormone therapy Evaluation for evidence of tumor spread is usually negative There is currently no effective therapy approved for use in these patients
The drug erlotinib works by blocking the activity of a protein called Epidermal Growth Factor Receptor EGFR which is located on the surface of many prostate cancer cells Blockage of this protein has been shown to inhibit the growth of prostate tumor cells in a laboratory setting and in animal experiments Erlotinib has been given to patients with other types of cancers A recently completed study showed that erlotinib improved the survival of patients with advanced lung cancer who failed standard chemotherapy
There is currently no effective therapy approved for use in patients with this condition The purpose of this study is to evaluate the effectiveness and side effects of the drug erlotinib in patients with this condition Erlotinib is an investigational drug that has not yet been approved by the Federal Drug Administration FDA for use in prostate cancer but has been approved for use in lung cancer
As previously stated The primary objective of this study is to evaluate the effect of erlotinib on the PSA response rate in patients with non-metastatic prostate cancer and a rising PSA on androgen deprivation therapy
Secondary objectives are to evaluate the effect of erlotinib on the duration of PSA response to evaluate the effect on the time to PSA progression to evaluate the toxicity of erlotinib in this patient population and lastly to correlate the effect of erlotinib with various EGFR-related proteins using baseline immunohistochemical IHC studies on tissue blocks and peripheral blood mononuclear cells
The drug erlotinib works by blocking the activity of a protein called Epidermal Growth Factor Receptor EGFR which is located on the surface of many prostate cancer cells Blockage of this protein has been shown to inhibit the growth of prostate tumor cells in a laboratory setting and in animal experiments Erlotinib has been given to patients with other types of cancers A recently completed study showed that erlotinib improved the survival of patients with advanced lung cancer who failed standard chemotherapy
There is currently no effective therapy approved for use in patients with this condition The purpose of this study is to evaluate the effectiveness and side effects of the drug erlotinib in patients with this condition Erlotinib is an investigational drug that has not yet been approved by the Federal Drug Administration FDA for use in prostate cancer but has been approved for use in lung cancer
As previously stated The primary objective of this study is to evaluate the effect of erlotinib on the PSA response rate in patients with non-metastatic prostate cancer and a rising PSA on androgen deprivation therapy
Secondary objectives are to evaluate the effect of erlotinib on the duration of PSA response to evaluate the effect on the time to PSA progression to evaluate the toxicity of erlotinib in this patient population and lastly to correlate the effect of erlotinib with various EGFR-related proteins using baseline immunohistochemical IHC studies on tissue blocks and peripheral blood mononuclear cells
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