Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077402
Status:
COMPLETED
Last Update Posted:
2013-05-15
First Post:
2004-02-10
Brief Title:
Fenretinide In Treating Patients With Advanced or Metastatic Hormone-Refractory Prostate Cancer
Sponsor:
Cancer Therapeutics Research Group
Organization:
National Cancer Institute NCI
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-6062 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000350305 | REGISTRY | None | None |