Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176293
Status:
TERMINATED
Last Update Posted:
2015-04-21
First Post:
2005-09-13
Brief Title:
Randomized Phase II Trial of Doxil With or Without Dexamethasone for Metastatic Hormone Refractory Prostate Cancer
Sponsor:
University of Kentucky
Organization:
University of Kentucky
Study Overview
Official Title:
A Randomized Phase II Trial of Doxil With or Without Dexamethasone in Treatment of Patients With Metastatic Hormone Refractory Prostate Cancer
Status:
TERMINATED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
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 assess disease response to Doxil in patients with hormone refractory prostate cancer with or without dexamethasone pre-treatment
Study Design
We will perform an open labeled parallel randomized phase II study using a two-stage design to determine if there is sufficient anti-tumor activity in either arm to warrant further study Assumptions made in this study an unacceptable overall response rate is 10 we will pursue further study if the overall response rate is 30 Fifteen patients will be randomized in the first phase to both Arm 1 and Arm 2 No further patients will be accrued if 215 responses are noted in a given arm Ten additional patients will be enrolled if 215 responses are observed If there are 525 responses then further studies will be pursued with that regimen We will determine the overall incidence severity of toxicities in both arms
Treatment
Arm 1 Doxil Dose 50 mgm2 IV in the vein on day 5 of each 28 day cycle Arm 2 Doxil Dose 50 mgm2 IV in the vein on day 5 of each 28 day cycle Arm 1 only Dexamethasone Dose 12 mg twice a day by mouth on days 1 2 3 4 5 of each 28 day cycle
Number of Cycles for both Arm 1 2 until progression or unacceptable toxicity develops
Study Design
We will perform an open labeled parallel randomized phase II study using a two-stage design to determine if there is sufficient anti-tumor activity in either arm to warrant further study Assumptions made in this study an unacceptable overall response rate is 10 we will pursue further study if the overall response rate is 30 Fifteen patients will be randomized in the first phase to both Arm 1 and Arm 2 No further patients will be accrued if 215 responses are noted in a given arm Ten additional patients will be enrolled if 215 responses are observed If there are 525 responses then further studies will be pursued with that regimen We will determine the overall incidence severity of toxicities in both arms
Treatment
Arm 1 Doxil Dose 50 mgm2 IV in the vein on day 5 of each 28 day cycle Arm 2 Doxil Dose 50 mgm2 IV in the vein on day 5 of each 28 day cycle Arm 1 only Dexamethasone Dose 12 mg twice a day by mouth on days 1 2 3 4 5 of each 28 day cycle
Number of Cycles for both Arm 1 2 until progression or unacceptable toxicity develops
Detailed Description:
Primary Objectives
To assess the anti-tumor activity of Doxil by assessing response rates in patients with hormone refractory prostate cancer with or without dexamethasone pre-treatment
Secondary Objectives
To assess and estimate in patients with hormone refractory prostate cancer treated with Doxil with or without pre-treatment dexamethasone 1 overall survival 2 toxicity 3 quality of life parameters 4 dose intensity administered in both treatment groups
Study Design
We will perform an open labeled parallel randomized phase II study using a two-stage design to determine if there is sufficient anti-tumor activity in either arm to warrant further study Assumptions made in this study an unacceptable overall response rate is 10 and we will pursue further study if the overall response rate is 30 The overall response rate for this study will be based on the total number of responses observed defined as complete responses partial responses both by RECISTbiochemical responses in patients with no measurable target lesions a 50 decrease in PSA for 4 weeks Fifteen patients will be randomized in the first phase to both Arm 1 and Arm 2 No further patients will be accrued if 215 responses are noted in a given arm Ten additional patients will be enrolled if 215 responses are observed If there are 525 responses then further studies will be pursued with that regimen We will determine the overall incidence and severity of toxicities in both arms
Treatment
Arm 1 Doxil Dose 50 mgm2 IV Frequency day 5 of each 28 day cycle Arm 2 Doxil Dose 50 mgm2 IV Frequency day 5 of each 28 day cycle Arm 1 only Dexamethasone Dose 12 mg bid po Frequency days 12345 of each 28 day cycle
Number of Cycles for both Arm 1 and 2 until progression or unacceptable toxicity develops
To assess the anti-tumor activity of Doxil by assessing response rates in patients with hormone refractory prostate cancer with or without dexamethasone pre-treatment
Secondary Objectives
To assess and estimate in patients with hormone refractory prostate cancer treated with Doxil with or without pre-treatment dexamethasone 1 overall survival 2 toxicity 3 quality of life parameters 4 dose intensity administered in both treatment groups
Study Design
We will perform an open labeled parallel randomized phase II study using a two-stage design to determine if there is sufficient anti-tumor activity in either arm to warrant further study Assumptions made in this study an unacceptable overall response rate is 10 and we will pursue further study if the overall response rate is 30 The overall response rate for this study will be based on the total number of responses observed defined as complete responses partial responses both by RECISTbiochemical responses in patients with no measurable target lesions a 50 decrease in PSA for 4 weeks Fifteen patients will be randomized in the first phase to both Arm 1 and Arm 2 No further patients will be accrued if 215 responses are noted in a given arm Ten additional patients will be enrolled if 215 responses are observed If there are 525 responses then further studies will be pursued with that regimen We will determine the overall incidence and severity of toxicities in both arms
Treatment
Arm 1 Doxil Dose 50 mgm2 IV Frequency day 5 of each 28 day cycle Arm 2 Doxil Dose 50 mgm2 IV Frequency day 5 of each 28 day cycle Arm 1 only Dexamethasone Dose 12 mg bid po Frequency days 12345 of each 28 day cycle
Number of Cycles for both Arm 1 and 2 until progression or unacceptable toxicity develops
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