Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201357
Status:
COMPLETED
Last Update Posted:
2016-03-25
First Post:
2005-09-13
Brief Title:
An Open Trial to Assess the Efficacy and Safety of Oral Thalidomide in Patients With Hormone-Refractory Prostate Cancer
Sponsor:
National Health Research Institutes Taiwan
Organization:
National Health Research Institutes Taiwan
Study Overview
Official Title:
An Open Non-Comparative Trial to Assess the Efficacy and Safety of Oral Thalidomide THADO in Patientswith Hormone-Refractory Prostate Cancer-A PHASE II CLINICAL TRIAL
Status:
COMPLETED
Status Verified Date:
2016-03
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:
Trial objectives The primary objective is to determine the proportion of patients who have 50 decrease in PSA maintained for at least 4 weeks in advanced hormone-refractory prostate cancer HRPC patients who receive thalidomide 100 mg BID Secondary objectives include the objective tumor response rate for measurable lesions the median duration of tumor response median time to disease progression and assessments of clinical benefits quality of life and safety profile
Detailed Description:
Trial objectives The primary objective is to determine the proportion of patients who have 50 decrease in PSA maintained for at least 4 weeks in advanced hormone-refractory prostate cancer HRPC patients who receive thalidomide 100 mg BID Secondary objectives include the objective tumor response rate for measurable lesions the median duration of tumor response median time to disease progression and assessments of clinical benefits quality of life and safety profile
Number of patient about 70 evaluable patients Simons optimal two-stage design will be used to allow early termination should sufficient evidence of non-effectiveness are collected Thalidomide is considered non-effective if the proportion of PSA response is 14 or lower and is worthy of further study if the proportion of response is 30 or higher Controlling the risk for accepting thalidomide when it is non-effective to be at most 5 and the risk for rejecting thalidomide when it is effective to be at most 10 this design calls for 26 patients at the first stage If four or less PSA response is observed then the study will be terminated Otherwise additional 44 patients will be entered at the second stage The treatment will be rejected if a total of 14 or less PSA responses are observed out of 70 patients This design has 70 chance of termination after the first stage if the true PSA response rate is 14 or lower With 70 patients the study will provide 95 assurance to claim that the difference between the estimated and true proportion will be within 11
Medication and Dose Thalidomide THADO 50mgcap 100mg BID
Duration Continue treatment until disease progression unacceptable toxicity or when patient meets any off-study criteria
Efficacy assessments of patients with 50 decrease in PSA maintained for at least 4 weeksObjective tumor response Median duration of tumor response Median time to disease progression Clinical benefits pain performance status weight
Quality of life evaluated by the instruments of EORTC-QLQ-C30 FACT-prostateSafety assessments
Toxicity -Adverse Event -Laboratory Test
Number of patient about 70 evaluable patients Simons optimal two-stage design will be used to allow early termination should sufficient evidence of non-effectiveness are collected Thalidomide is considered non-effective if the proportion of PSA response is 14 or lower and is worthy of further study if the proportion of response is 30 or higher Controlling the risk for accepting thalidomide when it is non-effective to be at most 5 and the risk for rejecting thalidomide when it is effective to be at most 10 this design calls for 26 patients at the first stage If four or less PSA response is observed then the study will be terminated Otherwise additional 44 patients will be entered at the second stage The treatment will be rejected if a total of 14 or less PSA responses are observed out of 70 patients This design has 70 chance of termination after the first stage if the true PSA response rate is 14 or lower With 70 patients the study will provide 95 assurance to claim that the difference between the estimated and true proportion will be within 11
Medication and Dose Thalidomide THADO 50mgcap 100mg BID
Duration Continue treatment until disease progression unacceptable toxicity or when patient meets any off-study criteria
Efficacy assessments of patients with 50 decrease in PSA maintained for at least 4 weeksObjective tumor response Median duration of tumor response Median time to disease progression Clinical benefits pain performance status weight
Quality of life evaluated by the instruments of EORTC-QLQ-C30 FACT-prostateSafety assessments
Toxicity -Adverse Event -Laboratory Test
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