Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT00077402
Status:
COMPLETED
Last Update Posted:
2013-05-15
First Post:
2004-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fenretinide In Treating Patients With Advanced or Metastatic Hormone-Refractory Prostate Cancer
Sponsor:
Cancer Therapeutics Research Group
Organization:
Study Overview
Official Title:
A Phase 2 Study Of Fenretinide In Patients With Hormone Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2006-12
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:
RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well fenretinide works in treating patients with advanced or metastatic hormone-refractory prostate cancer.
PURPOSE: This phase II trial is studying how well fenretinide works in treating patients with advanced or metastatic hormone-refractory prostate cancer.
Detailed Description:
OBJECTIVES:
Primary
* Determine the activity of fenretinide, in terms of the prostate-specific antigen (PSA) response rate, in patients with advanced or metastatic hormone-refractory prostate cancer.
Secondary
* Determine the objective response rate in patients with identifiable soft tissue disease treated with this drug.
* Determine the duration of PSA response in patients treated with this drug.
* Determine PSA progression-free survival of patients treated with this drug.
* Determine overall survival of patients treated with this drug.
* Determine the toxicity of this drug in these patients.
* Determine self-rated symptoms, functions, attitudes to oral therapy, and quality of life of patients treated with this drug.
OUTLINE: This is a multicenter, open-label study.
Patients receive oral fenretinide twice daily on days 1-7. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before each course, and at the end of therapy.
PROJECTED ACCRUAL: Approximately 21-50 patients will be accrued for this study.
Primary
* Determine the activity of fenretinide, in terms of the prostate-specific antigen (PSA) response rate, in patients with advanced or metastatic hormone-refractory prostate cancer.
Secondary
* Determine the objective response rate in patients with identifiable soft tissue disease treated with this drug.
* Determine the duration of PSA response in patients treated with this drug.
* Determine PSA progression-free survival of patients treated with this drug.
* Determine overall survival of patients treated with this drug.
* Determine the toxicity of this drug in these patients.
* Determine self-rated symptoms, functions, attitudes to oral therapy, and quality of life of patients treated with this drug.
OUTLINE: This is a multicenter, open-label study.
Patients receive oral fenretinide twice daily on days 1-7. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before each course, and at the end of therapy.
PROJECTED ACCRUAL: Approximately 21-50 patients will be accrued for this study.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: