Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00272038
Status:
COMPLETED
Last Update Posted:
2018-06-27
First Post:
2006-01-03
Brief Title:
Single Agent Erlotinib in Chemotherapy-naive Androgen Independent Prostate Cancer
Sponsor:
Oncology Specialists SC
Organization:
Oncology Specialists SC
Study Overview
Official Title:
Phase II Study Investigating the Efficacy and Activity of Single Agent Erlotinib in Chemotherapy-Naive Androgen Independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2018-05
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:
Objectives to evaluate the activity of Erlotinib in prostate cancer patients who are hormone refractory and androgen independent and have not been exposed to chemotherapy
Detailed Description:
This is a phase II open label single center study that evaluates the activity efficacy and toxicity of single agent Tarceva in chemotherapy-naive AIPC patients Patients will receive single agent Tarceva at 150 mg daily without interruption until disease progression unacceptable toxicity or investigators discretion Eligible patients are those with documented prostate cancer regardless of Gleason Score who are considered hormone refractory as defined below All patients must fail an anti-androgen withdrawal trial if they were already on such therapy If patients were on LHRH analogues alone they must fail the addition of an anti-androgen before being classified as hormone refractory All patients must have adequate organ functions as specified below and have an ECOG performance status of 2 or less It is hypothesized that 25 patients will be needed to adequately assess the activity of Tarceva in AIPC
The activity of Tarceva in other malignancies has been demonstrated with dosed ranging from 100 to 150 mg daily It is acceptable not to interrupt therapy unless toxicity occurs of disease progression is documented Starting patients at 150 mg daily seems to be the most logical step but dose reductions will be implemented based on side effects and adverse events
The activity of Tarceva in other malignancies has been demonstrated with dosed ranging from 100 to 150 mg daily It is acceptable not to interrupt therapy unless toxicity occurs of disease progression is documented Starting patients at 150 mg daily seems to be the most logical step but dose reductions will be implemented based on side effects and adverse events
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